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NCT04579341
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
NA trial testing probiotics in Diabetes Mellitus, Type 1 in 70 participants. Status unknown.
28 October 2020
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 21 January 2018 |
| Primary completion | 28 October 2020 |
| Estimated completion | 10 November 2020 |
| Sites | 2 locations across Egypt |
Drugs / interventions tested
- probiotics — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
Ain Shams University
Who can join
Adults 5 to 18, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration \> 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut microbiota in the pathogenesis and therapeutic approaches of diabetes.
Crudele L, Gadaleta RM, Cariello M, Moschetta A. · · 2023 · cited 147× · PMID 37804567 · DOI 10.1016/j.ebiom.2023.104821 -
Probiotic Supplementation Improves Glucose Homeostasis and Modulates Interleukin (IL)-21 and IL-22 Levels in Pediatric Patients with Type 1 Diabetes: A Randomized Placebo-Controlled Trial.
Adly AAM, Ismail EAR, Abd-Elgawad MM, Salah NY. · · 2025 · PMID 40422866 · DOI 10.3390/metabo15050288
Verify or expand the search:
- PubMed search for NCT04579341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Ain Shams University trials
Trials by the same sponsor.
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- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
- NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04579341 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 8 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04579341.
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