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NCT04851340 · ClinicalTrials.gov registry record · NA
Investigating the Detection of Bovine and Soy Proteins in Human Milk
A NA study of Stress and Microbiome, sponsored by University of Idaho.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04851340: Completed NA study of Stress and Microbiome, sponsored by University of Idaho.
NCT04851340 is a NA study of Stress and Microbiome that has completed, run by University of Idaho. The registered enrollment target is 38 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04851340, a NA study of Stress and Microbiome, has completed, sponsored by University of Idaho.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 2-day washout period. Participants (mother-offspring dyads) will be randomly assigned to order of interventions. Participants will be recruited as a convenience sample from mother-offspring dyads in the greater Moscow, Idaho and Boise, Idaho areas. The initial purpose of this study is to to learn more about the use of an allergen test strip to detect cow's milk and soy food allergen proteins in human milk, to identify soy and bovine-derived peptides in human milk after consumption of these foods, to explore the impact of maternal bovine milk and soy milk consumption on human milk and maternal/infant gastrointestinal microbiomes and to examine maternal stress during periods of dietary elimination and re-introductions periods.
Primary Outcome
This will be measured using a proprietary test strip developed for this purpose as well as LC-MS methodology.
Conditions Studied
Interventions
- OTHER Soy Milk
- OTHER Cow's Milk
Study Locations (1)
Idaho
- University of Idaho - Moscow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2021-08-31 |
| Phase | NA |
What the finished NCT04851340 record still lists
NCT04851340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Soy Milk is the first listed.
NCT04851340 reports a single indexed study location in Idaho.
Frequently Asked Questions
What is clinical trial NCT04851340 about?
NCT04851340 is a clinical study titled "Investigating the Detection of Bovine and Soy Proteins in Human Milk". This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 2-day washout period. Participants (mother-offspring dyads) will be randomly assigned to order of interventions. Participants will be recruited as a c...
What is the current status of trial NCT04851340?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2020-11-09. Estimated completion is 2021-08-31.
What conditions does trial NCT04851340 study?
This clinical trial studies the following conditions: Stress, Microbiome, Food Allergy in Infants.
What interventions are being tested in trial NCT04851340?
The interventions under investigation include: Soy Milk (OTHER), Cow's Milk (OTHER).
Who is sponsoring clinical trial NCT04851340?
This trial is sponsored by University of Idaho, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04851340 being conducted?
This trial has 1 study location across Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04851340's enrollment target sits among peer trials
38 123rd of 152 higher than 29 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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