Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function

NCT ID: NCT02727166

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-12-31

Brief Summary

Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.

Conditions

Functional Gastrointestinal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Inulin 8 g/d

Mixture of oligo- and polysaccharides composed of fructose units connected by β (2→1) links with a total number of fructose and glucose units ranging between 2 and 70.

Group Type: EXPERIMENTAL

Inulin

Intervention Type: DIETARY_SUPPLEMENT

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

maltodextrine 8 g/d

Group Type: PLACEBO_COMPARATOR

Maltodextrine

Intervention Type: DIETARY_SUPPLEMENT

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

Interventions

Inulin

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrine

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• negative sensation of digestive well-being (score ≤ 1 on at least 2 of the 6 evaluation days, scored on a - 5 / +5 scale.
• poor tolerance of a gas challenge test (abdominal perception score ≥ 3, on a 0-6 scale, for at least three 15-min time points over the last 90 minutes of the 180-minute-long intestinal gas infusion test).

Exclusion Criteria

• antibiotic intake,
• exceptional diets,
• changes in dietary habits or intake of Ca supplements over the preceding month.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Azpiroz, MD

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron Research Institute

Other Identifiers

PR(AG)168/2010

Identifier Type: -

Identifier Source: org_study_id