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

Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales

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.

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Dietary supplement: Inulin; Dietary supplement: Maltodextrine

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Inulin; Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
Placebo Comparator: maltodextrine 8 g/d	Dietary supplement: Maltodextrine; Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal gas retention	Effect of inulin intake (change from baseline with inulin versus placebo) on the volume of gas retention (volume infused minus volume evacuated) measured as the average value over the last 60 min of the gas infusion test.	60 last min of the 180 min gas infusion test
Digestive well-being	Effect of inulin intake (change from baseline with inulin versus placebo) on digestive well-being measured by daily questionnaires on - 5 to + 5 score scales and averaged over 6 days.	6 last days of intervention
Abdominal discomfort	Effect of inulin intake (change from baseline with inulin versus placebo) on abdominal discomfort measured by daily questionnaires on 0 to 10 score scales and averaged over 6 days.	6 last days of intervention
Bowel habit	Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days.	6 last days of intervention

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Fernando Azpiroz, MD, Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: intestinal gas; intestinal motility; functional gut symptoms; intestinal sensitivity
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: PR(AG)168/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED