Celiac Disease in ChildrenNCT06870643
Parabiotics Use with Nutritional Management in Pediatric Celiac Patients
A study testing Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks in people with Celiac Disease in Children, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2023to 20 Feb 2025
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification
Who cannot join
- Immunocompromised patients
- Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Parabiotics As an Adjuvant in Nutritional Management of Pediatric Celiac Patients
This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.
- Conditions
- Celiac Disease in Children
- Being tested
- Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeksOther
Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric celiac patients | Experimental | Strict gluten free food regimen for 3 weeks then parabiotics (Lacteolfort ®) added for another 3 weeks. Receives: Other: Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .
Evaluate the effect of parabiotics as an adjuvant therapy to gluten free diet in celiac patients' quality of life using pediatric quality of life(PedsQL)Gastrointestinal symptoms module version 3.0. It has specific gastrointestinal symptom domains, scoring from 0-4 (0 indicates never a problem, 1 indicates almost never a problem, 2 indicates sometimes a problem, 3 indicates often a problem and 4 indicates almost always a problem) then cores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The higher the score is the better quality of life, there is no cutoff value for this score.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 Jul 2023
- Primary completion26 Dec 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haya Essam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870643
- Sponsor's protocol ID
- FMASU M S 697/2022
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parabiotics As an Adjuvant in Nutritional Management of Pediatric Celiac Patients
- ClinicalTrials.gov ID
- NCT06870643
- Acronym / sponsor ID
- FMASU M S 697/2022
- Conditions
- Celiac Disease in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 11 Mar 2025 (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.
This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric celiac patients | Experimental | Other: Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeksStrict gluten free food regimen for 3 weeks then parabiotics (Lacteolfort ®) added for another 3 weeks. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification
Key exclusion criteria (2 listed)
- Immunocompromised patients
- Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
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 |
|---|---|---|
| Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeksGluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks. | Other | Pediatric celiac patients |
Primary outcome
Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .
Time frame: 3 weeks
Evaluate the effect of parabiotics as an adjuvant therapy to gluten free diet in celiac patients' quality of life using pediatric quality of life(PedsQL)Gastrointestinal symptoms module version 3.0. It has specific gastrointestinal symptom domains, scoring from 0-4 (0 indicates never a problem, 1 indicates almost never a problem, 2 indicates sometimes a problem, 3 indicates often a problem and 4 indicates almost always a problem) then cores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The higher the score is the better quality of life, there is no cutoff value for this score.
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 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Celiac Disease in Childhood-Adulthood Transition
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks in people with Celiac Disease in Children, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 2 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 19 Mar 2025. 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 Egypt. 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?
Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life . (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.