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Completed

NCT Number: NCT02140749

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

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).

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Key information

Conditions

Functional Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIZO food research

Ede, Gelderland, 6718ZB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sc-FOS 2g/day

Dietary Supplement

Chewing tablets containing Short-chain fructooligosaccharides 2g/day

Other names: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

sc-FOS 4g/day

Dietary Supplement

Chewing tablets containing short-chain Fructooligosaccharides 4g/day

Other names: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

sc-FOS 8g/day

Dietary Supplement

Chewing tablets containing short-chain Fructooligosaccharides 8g/day

Other names: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

Placebo

Dietary Supplement

Chewing tablets without short-chain Fructooligosaccharides

Primary outcomes

  1. Stool frequency (Number of complete bowel movements per day)

    Time frame: Change over week 4 and week 12

Secondary outcomes

  1. Stool consistency (Bristol Stool Scale)

    Time frame: Change over week 4 and week 12

  2. Severity of symptoms (Constipation Scoring System; CSS)

    Time frame: Change over week 4 and week 12

  3. Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)

    Time frame: Change over week 4 and week 12

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • Ingredion Incorporated

Registry information

Official study title

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

Acronym: TOMCAT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 16, 2014
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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