Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
Primary Purpose
Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inulin
Maltodextrine
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring intestinal gas, functional gut symptoms, intestinal sensitivity, intestinal motility
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Inulin 8 g/d
maltodextrine 8 g/d
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT02727166
First Posted
March 18, 2016
Last Updated
March 29, 2016
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02727166
Brief Title
Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
Official Title
Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
Keywords
intestinal gas, functional gut symptoms, intestinal sensitivity, intestinal motility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inulin 8 g/d
Arm Type
Experimental
Arm 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.
Arm Title
maltodextrine 8 g/d
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrine
Intervention Description
Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
Primary Outcome Measure Information:
Title
Perception of intestinal gas infusion
Description
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.
Time Frame
60 last min of the 180 min gas infusion test
Secondary Outcome Measure Information:
Title
Intestinal gas retention
Description
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.
Time Frame
60 last min of the 180 min gas infusion test
Title
Digestive well-being
Description
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.
Time Frame
6 last days of intervention
Title
Abdominal discomfort
Description
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.
Time Frame
6 last days of intervention
Title
Bowel habit
Description
Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days.
Time Frame
6 last days of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Azpiroz, MD
Organizational Affiliation
Vall d'Hebron Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
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