Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

October 12, 2021 updated by: Jiaomei Yang, Health Science Center of Xi'an Jiaotong University

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional 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.

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 (Actual)

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.
250

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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Xi'an Jiaotong University

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);
  2. Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); * Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months

Exclusion Criteria:

  1. Pregnant and lactating women;
  2. Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);
  3. Unclear main complaint and obvious abnormal mental state;
  4. The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);
  5. Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;
  6. Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week
  7. Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;
  8. Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;
  9. In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;
  10. Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.

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: Double

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.
Experimental: Group A
a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks
Dietary supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group B
a mixture of Fructooligosaccharide, water-soluble dietary fiber, polydextrose, and isomalt oligosaccharide, 12 g/d, 4 weeks
Dietary supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group C
a mixture of Polydextrose, wheat fiber, and Seed shell of Plantago rotundifolia, 12 g/d, 4 weeks
Dietary supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group D
a mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks
Dietary supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Placebo Comparator: Group E
Maltodextrin， 3 g/d, 4 weeks
Dietary supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.

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
Number of bowel movements per week
Time Frame: week 0 to 4
bowel movements will be recorded per week
week 0 to 4

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
Classification of bowel status
Time Frame: day 0, 14, 28
Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation
day 0, 14, 28
Bristol classification of stool characteristics
Time Frame: day 0, 14, 28
Bristol classification
day 0, 14, 28
glucose
Time Frame: day 0, 14, 28
Fasting plasma
day 0, 14, 28
HDL-C
Time Frame: day 0, 14, 28
Fasting plasma
day 0, 14, 28
LDL-C
Time Frame: day 0, 14, 28
Fasting plasma
day 0, 14, 28
TG
Time Frame: day 0, 14, 28
Fasting plasma
day 0, 14, 28
Tch
Time Frame: day 0, 14, 28
Fasting plasma
day 0, 14, 28
diversity and abundance of intestinal flora
Time Frame: day 0, 14, 28
16s rRNA
day 0, 14, 28

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.
Health Science Center of Xi'an Jiaotong University

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: Xin Liu, Health Science Center of Xi'an Jiaotong University

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 (Actual)

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.
August 15, 2020

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.
May 22, 2021

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.
September 30, 2021

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).
August 7, 2020

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.
December 14, 2020

First Posted (Actual)

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.
December 16, 2020

Study Record Updates

Last Update Posted (Actual)

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.
October 14, 2021

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.
October 12, 2021

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.
October 1, 2021

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.
  • 201911143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings