Last updated: September 5, 2023
Sponsor: PrecisionBiotics Group Ltd.
Overall Status: Completed
Phase
N/A
Condition
Gastrointestinal Diseases And Disorders
Colic
Dysmenorrhea (Painful Periods)
Treatment
Alflorex®
Clinical Study ID
NCT04922476
PBCT002A
Ages 8-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 8-18 years
- Any sex
- ROME IV diagnostic criteria Pediatric functional digestive disorders: in children andadolescents. H2. Functional abdominal pain disorders H2a. Functional dyspepsia H2b.Irritable bowel syndrome H2d. Functional abdominal pain not otherwise specified H3.Functional defecation disorders H3a. Functional constipation H3b. Non-retentive fecalincontinence Meet the criteria during the last three months with the onset symptomsfor at least six months before diagnosis
- IBS rated moderate to severe according to GSRS-IBS score (Spanish / LA)
- At least two episodes of abdominal pain per week
- No consumption of probiotics at least two weeks before baseline measurements (butpreferably four weeks);
- Dad, Mom, or Guardian able to understand the protocol;
- Be willing to maintain stable dietary habits throughout the study period;
- Be able to communicate well with the Investigator, to understand and comply with therequirements of the study and be judged suitable for the study in the opinion of theInvestigator;
- Signature of Informed Consent.
Exclusion
Exclusion Criteria:
- Children with systemic, organic or metabolic diseases, immunosuppression, differentfrom IBS
- Previous major abdominal surgery;
- Consumption of proton pump inhibitors, H2 antagonists;
- Consumption of probiotics in the two weeks before baseline measurements;
- Are less than 8 or older than 18 years of age at the time of consent;
- Subject who has been on antibiotics during the past 3 months;
- Subjects who have not had at least two episodes of abdominal pain per week;
- Subject with a malignant disease or any concomitant end-state organ disease and/orlaboratory abnormalities considered by Investigators to be risky or that couldinterfere with data collection;
- Subject who are coeliac or lactose intolerant;
- Known allergy to any of the components of the test product;
- Participation in a clinical study with an investigational product within 60 daysbefore screening, or plans to participate in another study during the study period;
- Subject has a history of non-compliance;
- Use of dietary supplements or other fermented foods that contain live bacteria.
- Pregnant or lactating females.
Study Design
Total Participants: 65
Treatment Group(s): 1
Primary Treatment: Alflorex®
Phase:
Study Start date:
August 06, 2021
Estimated Completion Date:
April 04, 2023
Study Description
Connect with a study center
Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile
Santiago,
ChileSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.