Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults (TOMCAT)

December 10, 2015 updated by: NIZO Food Research

Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Short-chain Fructooligosaccharides on Stool Frequency in Constipated Subjects

Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore, these dietary non-digestible carbohydrates might relieve functional constipation.

Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.

Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4 weeks.

Study population: Human subjects with functional constipation according to ROMEIII criteria (total n=120; male and female; 18-75 yr).

Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral chews.

Main study parameters: The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. Secondary outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • 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

  • Netherlands
    • Gelderland
      • Ede, Gelderland, Netherlands, 6718ZB
        • NIZO food research

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75 yr
  • Agree to study design (signed informed consent)

  • At least two of the following symptoms ≥25% of the time with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to inclusion (ROME III criteria for functional constipation):

    • straining, lumpy or hard stool
    • sensation of incomplete evacuation
    • sensation of anorectal obstruction ⁄ blockage
    • use of manual manoeuvres
    • <3 bowel movements per week
  • Availability of internet connection
  • BMI 20-30
  • Male or female
  • Willingness to abstain from functional ingredients and such as probiotics, prebiotics and foods containing high amounts of fermentable fibers and laxatives starting 1 month prior to start of the study as well as during the washout period.

Exclusion Criteria:

  • Currently participating in another clinical trial
  • Drug usage
  • Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)
  • Pregnancy or lactating
  • Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy
  • Use of antibiotics within 1 month prior to inclusion
  • Vegetarians
  • Weight loss > 5 kg within 1 month prior to inclusion

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sc-FOS 2g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks)
Dietary supplement: sc-FOS 2g/day
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
Other Names:
  • FOS
  • Oligofructose
  • scFOS
  • Short-chain fructo-oligosaccharide
Dietary supplement: Placebo
Chewing tablets without short-chain Fructooligosaccharides
Experimental: sc-FOS 4g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks)
Dietary supplement: Placebo
Chewing tablets without short-chain Fructooligosaccharides
Dietary supplement: sc-FOS 4g/day
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
Other Names:
  • FOS
  • Oligofructose
  • scFOS
  • Short-chain fructo-oligosaccharide
Experimental: sc-FOS 8g/day
Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks)
Dietary supplement: Placebo
Chewing tablets without short-chain Fructooligosaccharides
Dietary supplement: sc-FOS 8g/day
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
Other Names:
  • FOS
  • Oligofructose
  • scFOS
  • Short-chain fructo-oligosaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool frequency (Number of complete bowel movements per day)
Time Frame: Change over week 4 and week 12
Change over week 4 and week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool consistency (Bristol Stool Scale)
Time Frame: Change over week 4 and week 12
Change over week 4 and week 12
Severity of symptoms (Constipation Scoring System; CSS)
Time Frame: Change over week 4 and week 12
Change over week 4 and week 12
Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)
Time Frame: Change over week 4 and week 12
Change over week 4 and week 12

Collaborators and Investigators

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

Sponsor

NIZO Food Research

Collaborators

Ingredion Incorporated

Investigators

  • Principal Investigator: Sandra ten Bruggencate, PhD, NIZO food research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46640.081.14

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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