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

Overview

The aim of this study is to evaluate the effect of supplementation with thBifidobacterium longum 35624® Alflorex® on abdominal pain, symptoms and quality of life in children with Functional Gastrointestinal Disorders (FGIDs).

Full Title of Study: “Open Label Clinical Trial on the Efficacy of a Probiotic Strain of Bifidobacterium Longum 35624 (Alflorex®) in Functional Gastrointestinal Disorders (GFRS) in Children 8 to 18 Years of Age.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

Detailed Description

This is an open label study to assess the effectiveness & safety 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 100 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.

Interventions

  • Dietary Supplement: Alflorex®
    • Each probiotic capsule contains 1 x 10^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.

Arms, Groups and Cohorts

  • Experimental: Probiotic
    • Alflorex® The participants consume one probiotic capsule a day for 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in IBS symptom severity assessed by the GASTROINTESTINAL SYMPTOM RATING SCALE-IRRITABLE BOWEL SYNDROME (GSRS-IBS)
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • The GSRS-IBS measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.
  • Change in abdominal pain assessed by the Numeric Rating Scale for pain
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain which goes from 0 (no pain) to 10 (worst pain)

Secondary Measures

  • Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life
  • Change in stool consistency assessed using the Bristol Stool Form Scale
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • The Bristol Stool Form Scale classifies stool according to shape and consistency and assigns a sample a number from 1-7 depending on its characteristics, corresponding to constipation normal or diarrhea.
  • Change in stool frequency
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • Assessed from patient diaries
  • Change in days absent from school
    • Time Frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
    • Assess from patient diaries

Participating in This Clinical Trial

Inclusion Criteria

1. Age 8-18 years 2. Any sex 3. ROME IV diagnostic criteria Pediatric functional digestive disorders: in children and adolescents. 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 fecal incontinence Meet the criteria during the last three months with the onset symptoms for 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 (but preferably 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 the requirements of the study and be judged suitable for the study in the opinion of the Investigator; 10. Signature of Informed Consent. Exclusion Criteria:

1. Children with systemic, organic or metabolic diseases, immunosuppression, different from 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/or laboratory abnormalities considered by Investigators to be risky or that could interfere 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 days before 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.

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PrecisionBiotics Group Ltd.
  • Collaborator
    • Instituto de Nutrición y Tecnología de los Alimentos
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eileen Murphy, PhD, Study Director, PrecisionBiotics Group Ltd.
  • Overall Contact(s)
    • R&D Project Co-Ordinator, +353 21 4299104, eoherlihy@precisionbiotics.com

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