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

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Functional Gastrointestinal Disorders

Treatments: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02727166

PR(AG)168/2010

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups, including a placebo group

Inulin 8 g/d

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Inulin

maltodextrine 8 g/d

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrine