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

NIZO Food Research

Status: Completed

Conditions: Functional Constipation

Treatments: Dietary Supplement: Placebo; Dietary Supplement: sc-FOS 8g/day; Dietary Supplement: sc-FOS 2g/day; Dietary Supplement: sc-FOS 4g/day

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02140749

NL46640.081.14

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

sc-FOS 2g/day

Experimental group

Description:

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

Treatment:

Dietary Supplement: sc-FOS 2g/day

Dietary Supplement: Placebo

sc-FOS 4g/day

Experimental group

Description:

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

Treatment:

Dietary Supplement: sc-FOS 4g/day

Dietary Supplement: Placebo

sc-FOS 8g/day

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: sc-FOS 8g/day