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

NCT02140749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-12-11

No results posted yet for this study

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).

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

sc-FOS 2g/day

Chewing tablets containing Short-chain fructooligosaccharides 2g/day

DIETARY_SUPPLEMENT

sc-FOS 4g/day

Chewing tablets containing short-chain Fructooligosaccharides 4g/day

DIETARY_SUPPLEMENT

sc-FOS 8g/day

Chewing tablets containing short-chain Fructooligosaccharides 8g/day

DIETARY_SUPPLEMENT

Placebo

Chewing tablets without short-chain Fructooligosaccharides

Sponsors & Collaborators

  • Ingredion Incorporated

    collaborator INDUSTRY

  • NIZO Food Research

    lead OTHER

Principal Investigators

  • Sandra ten Bruggencate, PhD · NIZO Food Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140749 on ClinicalTrials.gov