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

Primary Purpose

Functional Constipation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
sc-FOS 2g/day
sc-FOS 4g/day
sc-FOS 8g/day
Placebo
Sponsored by
NIZO Food Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Functional Constipation focused on measuring Bifidobacteria, Bristol Stool Scale, Constipation, Diet, Fructooligosacchardes, Microbiota, Oligofructose

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NIZO food research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

sc-FOS 2g/day

sc-FOS 4g/day

sc-FOS 8g/day

Arm Description

Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks)

Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks)

Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks)

Outcomes

Primary Outcome Measures

Stool frequency (Number of complete bowel movements per day)

Secondary Outcome Measures

Stool consistency (Bristol Stool Scale)
Severity of symptoms (Constipation Scoring System; CSS)
Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)

Full Information

First Posted
April 24, 2014
Last Updated
December 10, 2015
Sponsor
NIZO Food Research
Collaborators
Ingredion Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02140749
Brief Title
Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
Acronym
TOMCAT
Official Title
Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Short-chain Fructooligosaccharides on Stool Frequency in Constipated Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NIZO Food Research
Collaborators
Ingredion Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
Bifidobacteria, Bristol Stool Scale, Constipation, Diet, Fructooligosacchardes, Microbiota, Oligofructose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sc-FOS 2g/day
Arm Type
Experimental
Arm Description
Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks)
Arm Title
sc-FOS 4g/day
Arm Type
Experimental
Arm Description
Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks)
Arm Title
sc-FOS 8g/day
Arm Type
Experimental
Arm Description
Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
sc-FOS 2g/day
Other Intervention Name(s)
FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Intervention Description
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
sc-FOS 4g/day
Other Intervention Name(s)
FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Intervention Description
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
sc-FOS 8g/day
Other Intervention Name(s)
FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Intervention Description
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Chewing tablets without short-chain Fructooligosaccharides
Primary Outcome Measure Information:
Title
Stool frequency (Number of complete bowel movements per day)
Time Frame
Change over week 4 and week 12
Secondary Outcome Measure Information:
Title
Stool consistency (Bristol Stool Scale)
Time Frame
Change over week 4 and week 12
Title
Severity of symptoms (Constipation Scoring System; CSS)
Time Frame
Change over week 4 and week 12
Title
Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)
Time Frame
Change over week 4 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra ten Bruggencate, PhD
Organizational Affiliation
NIZO Food Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIZO food research
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6718ZB
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.nizo.com
Description
Related Info

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

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