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

NCT04922476 | Completed DMC

• 1 other identifier: PBCT002A
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Functional Gastrointestinal Disorders; Functional Abdominal Pain

Keywords

Bifidobacterium longum 35624®; Probiotic; Food supplement; Alflorex®

Outcome Measures

Primary Outcomes (2)

• Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)

  The IBS-SSS measures symptom severity in IBS patients and is a reliable and validated questionnaire taking into account the composite score of abdominal pain, number of days with abdominal pain, bloating/distention, satisfaction with bowel habits and IBS-related quality of life. For this study, an adapted version was used in conjunction with the NRS-11 pain scale for the purposes of accurately capturing the response of a pediatric population. The NRS-11 pain scale goes from 0-10 with 0 indicating "no pain" and 10 indicating "very severe pain."

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

• Change in abdominal pain assessed by the Numeric Rating Scale for pain

  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)

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

Secondary Outcomes (4)

• Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

• Change in stool consistency assessed using the Bristol Stool Form Scale

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

• Change in stool frequency

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

• Change in days absent from school

  Change from baseline, assessed at 6 and 12 weeks of supplement intake

Study Arms (1)

Probiotic

EXPERIMENTAL

Alflorex® The participants consume one probiotic capsule a day for 12 weeks.

Dietary Supplement: Alflorex®

Interventions

Alflorex® DIETARY_SUPPLEMENT

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

Probiotic

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-18 years
• Any sex
• 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
• 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 (but preferably 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 the requirements of the study and be judged suitable for the study in the opinion of the Investigator;
• Signature of Informed Consent.

You may not qualify if:

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

Sponsors & Collaborators

• PrecisionBiotics Group Ltd.: lead
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator

Study Sites (1)

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

Santiago, Chile

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Eileen Murphy, PhD

  PrecisionBiotics Group Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: August 6, 2021
• Primary Completion: March 4, 2023
• Study Completion: April 4, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)