Probiotics and Gut Health

November 9, 2015 updated by: Société des Produits Nestlé (SPN)

Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Probiotic Food Product in Adults With Constipation

Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of ~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified clinical study, comparing three study arms (two quantities of the probiotic active component and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of the probiotic will be after fulfilling certain criteria at interim. After half of the subjects in the two study groups of high quantity and placebo have completed the study (40 subjects), an interim analysis will be performed. Depending on the observed effect size and the conditional power, the study may be stopped for futility, continued with the two groups or continued with inclusion of the third group of low dose probiotics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2AJ
        • Wingate Institute, Queen Mary University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult men or women
  • female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period
  • Age 18 - 65
  • BMI: 18.5 - 29.9 kg/m2
  • Symptoms of constipation for a minimum of 3 months
  • Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions):a). average Bristol stool type of 1 - 4 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week b). plus at least ONE of: straining on at least 25% of defaecations; sensation of incomplete evacuation on at least 25% of defaecations; sensation of anorectal obstruction / blockage on at least 25% of defaecations; use of manual manoeuvres on at least 25% of defaecations.
  • Cleveland Clinic constipation score (CCCS) of 8-15
  • Willing and able to consume a milk-based product daily for 4 weeks
  • Low-moderate fibre intake (≤18g) determined by the semi-quantitative food intake screener known as the Block Fibre Screener
  • No regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit, and no more than 6 standard doses in the past 1 month prior to the screening visit. Also, willing to discontinue fibre supplementation and other probiotics, prebiotics, fermented milk, yoghurt or laxatives at least 2 weeks prior to and during the consumption phase and the follow-up phase
  • Ability to understand the patient information sheet and instructions in English, and able to provide informed consent

Exclusion Criteria:

  • Subjects who report lactose intolerance and/or are allergic to cow milk protein or soya
  • Regular consumption of probiotics, fibre supplements (including prebiotics), fermented milk, yogurt, laxatives, or those unwilling to discontinue these at least 2 weeks prior to and during the study
  • Pregnant or breast-feeding women
  • Ongoing other diagnosed gastrointestinal disease or complication (e.g. IBS, Crohn's disease, Coeliac disease, chronic diarrhoea, etc.)
  • Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (<3 months), abdominal pain and stool positive for occult blood
  • Prior abdominal surgery (including gastric bypass or laparoscopic banding), except cholecystectomy and appendicectomy
  • Neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, Hirschsprung disease
  • Ongoing therapy with drugs known to affect gut motility, such as prokinetic agents (such as metoclopramide, domperidone, erythromycin, azithromycin), anti-emetic agents, anxiolytics (such as benzodiazepines), antidepressive agents (such as trycyclics, SSRI's etc.), narcotic analgesic agents (such as methadone, fentanyl), anticholinergic agents for IBS, medications for constipation (including enemas, cathartics, polyethylene glycol solutions), 5HT3 antagonists, anti-diarrheal agents (such as loperamide), opiate agents used to treat diarrhoea, NSAIDs (more than once daily), other antibiotics taken during or within 4 weeks of study onset, magnesium-containing antacids
  • Illness that may preclude the subject's ability to complete the study or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, severe cardiovascular disease, chronic renal failure or eating disorders) or any other serious illness resulting in >2 weeks inability to work in the 3 months before the study start
  • Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility)
  • HADS score of >11
  • Ongoing alcohol, drug, or medication abuse
  • Self-reported symptoms of pelvic organ prolapse
  • Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc
  • Participation in another study with any investigational product within 3 months of screening
  • Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: placebo
Experimental: High quantity probiotic food product
Other: High quantity probiotic
The intervention type is food product
Experimental: Low quantity probiotic food product
Other: Low quantity probiotic
The intervention type is food product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole gut transit time- 2 groups
Time Frame: After 2 weeks consumption of the study product
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing probiotics in high quantity, compared to those consuming placebo
After 2 weeks consumption of the study product

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional colonic transit time- all groups
Time Frame: After 2 weeks consumption of the study product
To evaluate change in the regional (right colon, left colon, and rectosigmoid)transit time 2 weeks after consumption of the study product in all groups
After 2 weeks consumption of the study product
Whole gut and Regional colonic transit time- all groups
Time Frame: After 4 weeks consumption of the study product
To evaluate the whole gut and regional colonic transit time after 4 weeks consumption of the study product in all study groups
After 4 weeks consumption of the study product
Whole gut transit time- all groups
Time Frame: After 2 weeks consumption of the study product
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in all groups
After 2 weeks consumption of the study product
Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups
Time Frame: After 2&4 weeks consumption of the study product
To evaluate change in Gastrointestinal symptoms 2&4 weeks after consumption of the study product in all groups
After 2&4 weeks consumption of the study product
Cleveland Clinic constipation score - all groups
Time Frame: After 1&2&4 weeks consumption of the study product
To evaluate change in Gastrointestinal symptoms 2&4 weeks after consumption of the study product in all groups
After 1&2&4 weeks consumption of the study product
Stool frequency- all groups
Time Frame: After 2&4 weeks consumption of the study product
Assessed through daily bowel diary records for each bowel movement
After 2&4 weeks consumption of the study product
Stool consistency - all groups
Time Frame: After 2&4 weeks consumption of the study product
To evaluate stool form (Bristol stool scale) 2&4 weeks after consumption of the study product in all groups
After 2&4 weeks consumption of the study product
Response to the constipation quality of life (PAC-QOL)questionnaires - all groups
Time Frame: After 2&4 weeks consumption of the study product
To evaluate change in quality of life 2&4 weeks after consumption of the study product in all groups
After 2&4 weeks consumption of the study product
Tolerance to the study product- all groups
Time Frame: After 2&4 weeks consumption of the study product
Response to tolerance questionnaire 2&4 weeks after consumption of the study product in all groups
After 2&4 weeks consumption of the study product
Global Constipation Symptom Score - all groups
Time Frame: After 1&2&4 weeks consumption of the study product
To evaluate change in Gastrointestinal symptoms 2&4 weeks after consumption of the study product in all groups
After 1&2&4 weeks consumption of the study product
Ease of passage - all groups
Time Frame: After 2&4 weeks consumption of the study product
Assessed through daily bowel diary records for each bowel movement
After 2&4 weeks consumption of the study product

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Through the study product consumption period (4 weeks)
Adverse events assessed as treatment emergent adverse events (TEAEs)
Through the study product consumption period (4 weeks)
Correlation between lifestyle, diet and blood/stool biomarkers with gut function and symptoms- all groups
Time Frame: After 2&4 weeks consumption of the study product
To evaluate correlation between lifestyle, diet and blood/stool biomarkers with gut function and symptoms, 2&4 weeks after consumption of the study product in all groups
After 2&4 weeks consumption of the study product
Long-term changes in gut function and gastrointestinal symptoms
Time Frame: After 4 weeks follow-up (week 8)
To assess long-term changes in gut function and gastrointestinal symptoms 4 weeks after the end of the study product consumption period in all study groups
After 4 weeks follow-up (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Scott, PhD, Wingate Institute, Queen Mary University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12.05.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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