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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922476
• Other study ID #: PBCT002A
• Status: Completed
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: September 2023
• Source: PrecisionBiotics Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 4, 2023
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Digestive System Diseases
• Functional Abdominal Pain
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Chile	Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
PrecisionBiotics Group Ltd.	Instituto de Nutrición y Tecnología de los Alimentos

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in quality of life assessed by the Irritable Bowel Syndrome-Quality of Life questionnaire	The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life	Change from baseline, assessed at 6 and 12 weeks of supplement intake
Secondary	Change in stool consistency assessed using the Bristol Stool Form Scale	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 from baseline, assessed at 6 and 12 weeks of supplement intake
Secondary	Change in stool frequency	Assessed from patient diaries	Change from baseline, assessed at 6 and 12 weeks of supplement intake
Secondary	Change in days absent from school	Assess from patient diaries	Change from baseline, assessed at 6 and 12 weeks of supplement intake