Effect of B-GOS on GI Discomfort in Healthy Adults

Double-blind, Placebo Controlled, Randomised, Multicentered, of Parallel Design Study to Determine the Effect of B-GOS on GI Discomfort in Healthy Adults

The aim of the study is to evaluate the effects of a new food supplement which is currently available in the market, called Bimuno® (B-GOS), on gastrointestinal discomfort (e.g. bloating, abdominal pain/cramp and flatulence) in adults who often experience these symptoms but are otherwise healthy.

About 400 volunteers will take part in this study, which will last 6 weeks (to include 4 weeks treatment and 2 weeks follow up period).

Episodes of abdominal pain or discomfort (e.g. bloating, abdominal pain/cramp and flatulence), in the absence of diseases, are commonly associated with food or drug intake or with alterations of bowel habit and vary between individuals in frequency and severity.

Some dietary ingredients are known to reduce these symptoms. We have used B-GOS previously in trials with healthy younger and older adults and we have observed a trend towards reducing abdominal bloating. However, the investigators have not tested B-GOS in healthy adults who often experience these symptoms and this is what we will investigate now.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: B-GOS

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX11 9LH
    • Research Insights Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged between 18 and 65 years old.
2. Presence of bloated feeling or experiencing abdominal fullness, with or without visible distention, often in the last 12 months.
3. Ability to communicate well with the investigator and to comply with the requirements of the entire study.
4. Volunteer has given written informed consent to participate and is willing to participate in the entire study.

Exclusion Criteria:

1. History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
2. Undergone surgical resection of any part of the bowel.
3. History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
4. Received antibiotics in the previous four weeks.
5. Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
6. Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous one month, or intention to use such drugs during the course of the study.
7. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.
8. Regular use of any medication with exception of hormonal replacement therapy and contraception.
9. Women who are pregnant or breast-feeding.
10. Fertile women not practicing a medically-approved method of contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B-GOS; 2.75g daily for 4 weeks	Dietary supplement: B-GOS; Other Names: Bimuno
Placebo Comparator: Maltodextrin; 2.75g daily for 4 weeks	Dietary supplement: Maltodextrin; Other Names: corn syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of B-GOS on GI discomfort	questionnaires	Participants will be followed daily for 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To conduct an assessment of stools	questionnaires	Participants will be followed daily for 6 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of B-GOS on the quality of life and general well being.	questionnaires	beginning and end of the study

Collaborators and Investigators

• Sponsor: Clasado Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CLAS/1213