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

Functional Constipation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140749
• Other study ID #: NL46640.081.14
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: December 10, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: NIZO Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• sc-FOS 2g/day
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
• sc-FOS 4g/day
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
• sc-FOS 8g/day
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
• Placebo
Chewing tablets without short-chain Fructooligosaccharides

Locations

Country	Name	City	State
Netherlands	NIZO food research	Ede	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
NIZO Food Research	Ingredion Incorporated

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool frequency (Number of complete bowel movements per day)		Change over week 4 and week 12	No
Secondary	Stool consistency (Bristol Stool Scale)		Change over week 4 and week 12	No
Secondary	Severity of symptoms (Constipation Scoring System; CSS)		Change over week 4 and week 12	No
Secondary	Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)		Change over week 4 and week 12	No

External Links

•   Link