Abdominal bloating Digestive System
Conditions
Interventions
The investigational product (IP) is a mixture of five live freeze-dried Lactobacillus & Bifidobacterium strains. Microcrystalline cellulose (MCC) is added to the active blend as an inert carrier, and
Sponsors
Danisco Sweeteners Oy
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this clinical trial are to assess the effect of 2-week supplementation of a probiotic blend (or placebo) on the following parameters in adults with self-reported bloating and constipation: 1. Colonic transit time (CTT), determined by the amount of ingested ROMs visualized with X-ray 2. Participant assessment of digestive symptoms in addition to bloating (abdominal pain, flatulence/gas and borborgymi/burbling/rumbling), assessed daily for 14 days (Day 0 to Day 14) with an eDiary together with the primary outcome 3. Defecation frequency and stool consistency, assessed daily for 14 days (Day 0 to Day 14) with an eDiary together with the primary outcome 4. Constipated-related PAC-SYM and PAC-Qol questionnaries, assessed at baseline (Day 0) and at the end of the intervention (Day 14) 5. Faecal microbial analysis, assessed at baseline (within Day -6 until Day 0), and at the end of intervention (within Day 8 until Day 14) 6. Overall product satisfaction, evaluated at the end of the intervention (Day 14) Safety of the investigational product will be evaluated throughout the study on the basis of serious and non-serious adverse events, as outlined in Adverse Events. | — |
Countries
Ireland
Contacts
Public ContactMary Osborne
Outcome results
None listed