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

Study Overview
=================
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).

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

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: sc-FOS 2g/day
* Dietary Supplement: sc-FOS 4g/day
* Dietary Supplement: sc-FOS 8g/day
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sc-FOS 2g/day<br>Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks) | Dietary Supplement: sc-FOS 2g/day<br>* Chewing tablets containing Short-chain fructooligosaccharides 2g/day<br>* Other names: Short-chain fructo-oligosaccharide;Dietary Supplement: Placebo<br>* Chewing tablets without short-chain Fructooligosaccharides<br>|
| Experimental: sc-FOS 4g/day<br>Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks) | Dietary Supplement: sc-FOS 4g/day<br>* Chewing tablets containing short-chain Fructooligosaccharides 4g/day<br>* Other names: Short-chain fructo-oligosaccharide;Dietary Supplement: Placebo<br>* Chewing tablets without short-chain Fructooligosaccharides<br>|
| Experimental: sc-FOS 8g/day<br>Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks) | Dietary Supplement: sc-FOS 8g/day<br>* Chewing tablets containing short-chain Fructooligosaccharides 8g/day<br>* Other names: Short-chain fructo-oligosaccharide;Dietary Supplement: Placebo<br>* Chewing tablets without short-chain Fructooligosaccharides<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency (Number of complete bowel movements per day) |  | Change over week 4 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Bifidobacteria, Bristol Stool Scale, Constipation, Fructooligosacchardes, Microbiota, Oligofructose