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

NCT02140749 | Completed DMC

• 1 other identifier: NL46640.081.14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Constipation

Keywords

Bifidobacteria; Bristol Stool Scale; Constipation; Diet; Fructooligosacchardes; Microbiota; Oligofructose

Outcome Measures

Primary Outcomes (1)

• Stool frequency (Number of complete bowel movements per day)

  Change over week 4 and week 12

Secondary Outcomes (3)

• Stool consistency (Bristol Stool Scale)

  Change over week 4 and week 12

• Severity of symptoms (Constipation Scoring System; CSS)

  Change over week 4 and week 12

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

  Change over week 4 and week 12

Study Arms (3)

sc-FOS 2g/day

EXPERIMENTAL

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

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

sc-FOS 4g/day

EXPERIMENTAL

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

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

sc-FOS 8g/day

EXPERIMENTAL

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

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

Interventions

sc-FOS 2g/day DIETARY_SUPPLEMENT

Chewing tablets containing Short-chain fructooligosaccharides 2g/day

Also known as: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

sc-FOS 2g/day

sc-FOS 4g/day DIETARY_SUPPLEMENT

Chewing tablets containing short-chain Fructooligosaccharides 4g/day

Also known as: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

sc-FOS 4g/day

sc-FOS 8g/day DIETARY_SUPPLEMENT

Chewing tablets containing short-chain Fructooligosaccharides 8g/day

Also known as: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide

sc-FOS 8g/day

Placebo DIETARY_SUPPLEMENT

Chewing tablets without short-chain Fructooligosaccharides

sc-FOS 2g/day; sc-FOS 4g/day; sc-FOS 8g/day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 yr
• Agree to study design (signed informed consent)
• 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.

You may not qualify if:

• 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
• Vegetarians

Sponsors & Collaborators

• NIZO Food Research: lead
• Ingredion Incorporated: collaborator

Study Sites (1)

NIZO food research

Ede, Gelderland, 6718ZB, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Conditions

Constipation

Interventions

oligofructose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra ten Bruggencate, PhD

  NIZO Food Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 16, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

NL (1)