Trials / Completed
CompletedNCT04922476
Effect of 35624® Alflorex® in Functional Gastrointestinal Disorders (FGIDs) in Children.
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- PrecisionBiotics Group Ltd. · Industry
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-08-06
- Primary completion
- 2023-03-04
- Completion
- 2023-04-04
- First posted
- 2021-06-10
- Last updated
- 2023-09-08
Locations
1 site across 1 country: Chile
Source: ClinicalTrials.gov record NCT04922476. Inclusion in this directory is not an endorsement.