Effect of a probiotic blend on bloating and colonic transit time in participants with self-reported bloating and constipatio

Not Applicable

Completed

• Conditions: Abdominal bloating; Digestive System

• Registration Number: ISRCTN41607808
• Lead Sponsor: Danisco Sweeteners Oy

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31131616 (added 29/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-02
• Study Completion: 2016-02-26
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1. Age 18 - 70
2. Obtained his/her informed consent after verbal and written information
3. Sufficient general health and orientation for participating in the study
4. Have a high probability for compliance with and completion of the study
5. Functional constipation or constipation predominant IBS according to Rome III criteria
6. Bowel movement frequency 1-3/week
7. Stool consistency 1-2 according to Bristol Stool Scale Form for most spontaneously passed stools
8. Self-reported bloating at least twice a week
9. No continuous use of probiotics or probiotic containing product or drug within 1 month prior to screening

Exclusion Criteria

1. Participation in a clinical trial with an investigational product or drug within 2 months prior to screening
2. Likeliness to be non-compliant with the protocol, or to be unsuitable to the study by the investigator for any reason
3. Planned major changes in life style (diet, exercise level, travelling)
4. Eating disorder
5. Pregnant or breastfeeding women; women planning to become pregnant during the study
6. Subject under administrative or legal supervision
7. Diagnosed or suspected organic gastrointestinal disease
8. Severely impaired general health including cancer and cancer therapy
9. Prior major abdominal surgery
10. Lactose intolerance if the subject does not follow a lactose-restricted diet
11. Previous anaphylaxis type reaction to any substance in composition of the study product
12. Consumption of or unwillingness to refrain from the use of commercial probiotics or prebiotics during the trial
13. Laxative use within 48 hours of screening and regular use of laxatives (rescue medication allowed for intolerable symptoms during study)
14. Regular use of any drug or dietary supplement known to cause constipation as a common side effect (e.g. iron, opioids, sucralfate misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, anti-diarrheal medication, anti-cholinergic agents, calcium supplements, tricyclic anti-depressants or NSAIDs) within 1 month prior to the study randomization
15. History of drug or alcohol abuse
16. Subject has been on antibiotics within 1 month of screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the present clinical trial is to independently assess the effect of orally administered 2-week supplementation of a probiotic blend (or placebo) on bloating in general adult population with self-reported bloating and constipation. The probiotic blend (or placebo) will be administered in capsules (1 capsule daily) for 14 days (for strain-wise dosages in a capsule, see Table 1). The bloating severity and the number of days with bloating will be determined for 14 days with a daily eDiary using visual analogue scale (VAS). The primary endpoint will be a composite score of percentage of days with bloating times the average severity of the VAS, frequency*severity.