Functional Gastrointestinal DisordersNCT04922476

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

A study testing Alflorex® in people with Functional Gastrointestinal Disorders and Functional Abdominal Pain, run by PrecisionBiotics Group Ltd. at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 8 to 18 years
Conditions the study is for: Functional Gastrointestinal Disorders, Functional Abdominal Pain
What is being tested?: Alflorex®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteChile
Study dates: 6 Aug 2021to 4 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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);

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

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

Other trials in Chile

About this study

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.

Read the 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: Functional Gastrointestinal Disorders, Functional Abdominal Pain
Being tested: Alflorex®
Keywords: Bifidobacterium longum 35624®, Probiotic, Food supplement, Alflorex®
Medical subject headings: Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04922476
Study group	Role	What they receive
Probiotic	Experimental	Alflorex® The participants consume one probiotic capsule a day for 12 weeks. Receives: Dietary Supplement: Alflorex®

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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)
Measured: 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
The IBS-QOL scoring is from 0 to 100, with higher scores indicating better IBS specific quality of life
Measured: Change from baseline, assessed at 6 and 12 weeks of supplement intake
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.
Measured: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in stool frequency
Assessed from patient diaries
Measured: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in days absent from school
Assess from patient diaries
Measured: Change from baseline, assessed at 6 and 12 weeks of supplement intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 20214 Apr 2023

First posted10 Jun 2021
Study start6 Aug 2021
Primary completion4 Mar 2023
Study completion4 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04922476
Sponsor's protocol ID: PBCT002A
Status last verified: Sep 2023
First submitted: 4 Jun 2021
Last updated: 8 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Functional Gastrointestinal Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04922476
Acronym / sponsor ID: PBCT002A
Conditions: Functional Gastrointestinal Disorders, Functional Abdominal Pain
Keywords: Bifidobacterium longum 35624®, Probiotic, Food supplement, Alflorex®
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: PrecisionBiotics Group Ltd.Industry (pharma, biotech, devices)
Collaborators: Instituto de Nutrición y Tecnología de los Alimentos
Study start: 6 Aug 2021 (actual)
Primary completion: 4 Mar 2023 (actual)
Study completion: 4 Apr 2023 (actual)
First posted: 10 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Probiotic	Experimental	Dietary Supplement: Alflorex®Alflorex® The participants consume one probiotic capsule a day for 12 weeks.

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alflorex®Each probiotic capsule contains 1 x 10^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.	Dietary supplement	Probiotic

Primary outcome

Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS)
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
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
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)

4 secondary outcomes

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
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
Change in stool frequency
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake
Change in days absent from school
Time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
Individual participant dataSharing planned: No

Related trials for Functional Gastrointestinal Disorders

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Recruiting
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eileen Murphy, PhD study director

PrecisionBiotics Group Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alflorex® in people with Functional Gastrointestinal Disorders and Functional Abdominal Pain, run by PrecisionBiotics Group Ltd. at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in IBS symptom severity assessed by an adapted Irritable Bowel Symptom Severity Scoring System (IBS-SSS) (time frame: Change from baseline, assessed at 6 and 12 weeks of supplement intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04922476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.