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NCT05215080: TOFeM
The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants
NA trial testing Organic Formula Milk in Food Allergy in Infants in 50 participants. Completed in 31 May 2022.
7 March 2022
Quick facts
| Lead sponsor | Hasanuddin University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 7 December 2021 |
| Primary completion | 7 March 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Organic Formula Milk
Conditions studied
- Food Allergy in Infants — all drugs for Food Allergy in Infants →
Sponsor
Hasanuddin University
Who can join
Adults 6 Months to 7 Months, any sex, with Food Allergy in Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This interventional study aims to investigate the tolerance of organic formula milk on infants supplemented with organic formula milk. This study also observes gut microbiota, short chain fatty acids, nutritional status, and atopic manifestation on infants supplemented with organic formula milk. This study will be done on 50 subjects, with an age of 6-7 months old, 38-42 weeks of gestation, had a birth weight ranging from 2700 grams to 4200 grams, not suffering from any major congenital anomaly, not severely stunted at birth, has a normal thyroid function, not suffering any prominent gastrointestinal disease, not having a severe disease at the beginning of study, and has an approval from their parents. Participants' diet will be added an organic formula for infant for 3 months, and will be monitored regularly, since this study starts, at each month, and at the end of this study. The participants' gut microbiomes will be calculated at every session of monitoring by collecting their fecal samples, and brought to laboratory. Anthropological data (weight, height, body mass index), atopic manifestation, IL-6 and IL-10 will also be collected.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05215080
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Related trials
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Other Hasanuddin University trials
Trials by the same sponsor.
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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 NCT05215080 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hasanuddin University
- Last refreshed: 13 July 2022
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/NCT05215080.
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