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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02140749
Other study ID # NL46640.081.14
Secondary ID
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


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
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Completed NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT02359396 - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics Phase 1
Completed NCT01847950 - Effects of scFOS on Stool Frequency in People With Functionnal Constipation N/A
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