A double blind, randomized, controlled trial to evaluate the effects of the consumption of a fermented milk drink on bowel function in adults

Yakult Honsha Co. Ltd0 sites100 target enrollmentAugust 29, 2017

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Males and non\- pregnant females aged from 18 to 70 years
•2\. Body mass index (BMI) \>18\.0 and \<30 kg/m2
•3\. Diagnosed as a subgroup of functional constipation, fulfilling Rome III criteria for functional constipation and have a defecation frequency of \<3 SBMs per week with a diagnosis of \>3 months and with symptom onset at least 6 months before diagnosis at the screening visit V0\. Subjects are required to have BM frequency \<3 CSBMs per week at the baseline visit V1 during the 2 weeks before randomization.
•4\. Agree to avoid using any laxative during the baseline period and the study period except in the case the investigator allows him/her to have rescue medication
•5\. No use of laxatives within 15 days before baseline
•6\. No consumption of forbidden foods in the previous 30 days before V0 (according to the list of forbidden foods A)
•7\. Ability of the participant (in the investigator’s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
•8\. Consent to the study and willing to comply with study product and method
•9\. Agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state (according to the forbidden food list) and not to make any major lifestyle changes (e.g. changing their exercise pattern) during the trial

•1\. Neurological, pharmacological or organic cause for constipation
•2\. Subjects with 3 or more CSBMs at week \-2 or at week \-1
•3\. Habitual users of laxatives, since 3 months before enrolment
•4\. Major neurological disease or injury (e.g. Multiple sclerosis, Spinal Cord Injury \- SCI)
•5\. Major gastrointestinal complication (e.g. Crohn’s disease, colitis, celiac disease, lactose intolerance and allergy to cow\-milk proteins).
•6\. Febrile diverticulitis within 1 year before enrolment
•7\. Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, except appendectomy, haemorrhoidectomy and cholecystectomy
•8\. Any subject who on first assessment has symptoms requiring urgent medical assessment or treatment (e.g. rectal bleeding which requires endoscopy)
•9\. Any subject that present abdominal pain as a predominant symptom
•10\. Any subject that need manual maneuvers (digital insertion into the rectum, perianal pressure or vaginal splinting) to evacuate stools.