Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Oligofructose on Stool Frequency in Constipated subjects

Completed

Conditions: constipation
decreased frequency of defecation
10017977

Registration Number: NL-OMON40415

Lead Sponsor: Ingredion Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Age 18-75 yr
• Agree to study design (signed informed consent)
• At least two of the following symptoms >=25% of the defecations (ROME III) with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to study start:
o straining, lumpy or hard stool
o sensation of incomplete evacuation
o sensation of anorectal obstruction * blockage
o use of manual manoeuvres
o <3 bowel movements per week
• Availability of internet connection
• BMI 20-30
• Male and/or female
• Willingness to abstain from functional ingredients and such as probiotics, prebiotics, foods containing high amounts of fermentable fibers, and laxatives during the study.

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

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary parameter is the number of complete bowel movements per day in<br /><br>subjects with functional constipation according to Rome III criteria. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are Stool consistency (Bristol Stool Scale), Stool<br /><br>frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality<br /><br>of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL).<br /><br><br /><br>Other study parameters:<br /><br>Microbiota profile, fecal Bifidobacteria, Lactobacilli, Clostridia, E. coli and<br /><br>total bacterial count. Blood samples will be taken at baseline and end of<br /><br>treatment and stored for later analysis.</p><br>