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

NCT02727166 | Completed

• 1 other identifier: PR(AG)168/2010
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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

Keywords

intestinal gas; functional gut symptoms; intestinal sensitivity; intestinal motility

Outcome Measures

Primary Outcomes (1)

• Perception of intestinal gas infusion

  Effect of inulin intake (change from baseline with inulin versus placebo) on the tolerance of the gas challenge test, measured as the perception score of digestive sensations during the gas challenge test. At each time point, the highest score instead of the mean or cumulative scores will be computed for comparisons; these scores will be averaged over the last 60 min of the test in each subject; the differences between basal and intervention periods (inulin or placebo) will be calculated.

  60 last min of the 180 min gas infusion test

Secondary Outcomes (4)

• Intestinal gas retention

  60 last min of the 180 min gas infusion test

• Digestive well-being

  6 last days of intervention

• Abdominal discomfort

  6 last days of intervention

• Bowel habit

  6 last days of intervention

Study Arms (2)

Inulin 8 g/d

EXPERIMENTAL

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.

Dietary Supplement: Inulin

maltodextrine 8 g/d

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrine

Interventions

Inulin DIETARY_SUPPLEMENT

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

Inulin 8 g/d

Maltodextrine 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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Inulin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Fernando Azpiroz, MD

  Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 4, 2016
• Study Start: November 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2016

Record last verified: 2016-03