Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.

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

The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of abdominal pain using an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) to accurately reflect the pediatric population using the aid of the validated Numeric Pain Rating Scale (NRS-II) in children with Functional Gastrointestinal Disorders (FGIDs).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 8-18 years
  2. Any sex
  3. 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
  4. IBS rated moderate to severe according to GSRS-IBS score (Spanish / LA)
  5. At least two episodes of abdominal pain per week
  6. No consumption of probiotics at least two weeks before baseline measurements (butpreferably four weeks);
  7. Dad, Mom, or Guardian able to understand the protocol;
  8. Be willing to maintain stable dietary habits throughout the study period;
  9. 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;
  10. Signature of Informed Consent.

Exclusion

Exclusion Criteria:

  1. Children with systemic, organic or metabolic diseases, immunosuppression, differentfrom IBS
  2. Previous major abdominal surgery;
  3. Consumption of proton pump inhibitors, H2 antagonists;
  4. Consumption of probiotics in the two weeks before baseline measurements;
  5. Are less than 8 or older than 18 years of age at the time of consent;
  6. Subject who has been on antibiotics during the past 3 months;
  7. Subjects who have not had at least two episodes of abdominal pain per week;
  8. 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;
  9. Subject who are coeliac or lactose intolerant;
  10. Known allergy to any of the components of the test product;
  11. Participation in a clinical study with an investigational product within 60 daysbefore screening, or plans to participate in another study during the study period;
  12. Subject has a history of non-compliance;
  13. Use of dietary supplements or other fermented foods that contain live bacteria.
  14. 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

This is an open label study to assess the safety and effectiveness of Bifidobacterium longum 35624® Alflorex® when consumed once daily by children with Functional Gastrointestinal Disorders (FGIDs). The 12-week intervention study will be conducted in 63 non-coeliac children aged 8 to 18 years old with an FGID who experience at least two episodes of abdominal pain per week. The study will consist of 5 visits over a 14 week period commencing with a screening visit. The second visit will be the baseline (start of intervention), followed by third (mid-intervention), fourth (end of treatment) and fifth (follow up) visit. Questionnaires will be administered from the second to the fifth visit. A blood sample will be taken before treatment to rule out coeliac disease.

Connect with a study center

  • Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile

    Santiago,
    Chile

    Site Not Available

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