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

Primary Purpose

Functional Gastrointestinal Disorders, Functional Abdominal Pain

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Alflorex®

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Bifidobacterium longum 35624®, Probiotic, Food supplement, Alflorex®

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm Description

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

Outcomes

Primary Outcome Measures

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 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)

Secondary Outcome Measures

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 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 in stool frequency

Assessed from patient diaries

Change in days absent from school

Assess from patient diaries

Full Information

NCT ID

NCT04922476

First Posted

June 4, 2021

Last Updated

September 5, 2023

Sponsor

PrecisionBiotics Group Ltd.

Collaborators

Instituto de Nutrición y Tecnología de los Alimentos

1. Study Identification

Unique Protocol Identification Number

NCT04922476

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

March 4, 2023 (Actual)

Study Completion Date

April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PrecisionBiotics Group Ltd.

Collaborators

Instituto de Nutrición y Tecnología de los Alimentos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Gastrointestinal Disorders, Functional Abdominal Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Alflorex®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

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)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life

Time Frame

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

Title

Change in stool consistency assessed using the Bristol Stool Form Scale

Description

Time Frame

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

Title

Change in stool frequency

Description

Assessed from patient diaries

Time Frame

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

Title

Change in days absent from school

Description

Assess from patient diaries

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eileen Murphy, PhD

Organizational Affiliation

PrecisionBiotics Group Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Santiago

Country

Chile

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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