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Synbiotics Cohort Study

Sponsor
Nutricia UK Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05046418
Collaborator
(none)
60
Enrollment
1
Location
35.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypoallergenic formula containing synbiotics

Detailed Description

A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged <13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae With Synbiotics in Infants With Cow's Milk Allergy
Actual Study Start Date :
Sep 5, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Hypoallergenic formula containing synbiotics

Infants (aged <13 months) with cow's milk allergy (CMA) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of CMA.

Other: Hypoallergenic formula containing synbiotics
An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.

Outcome Measures

Primary Outcome Measures

  1. Healthcare use [6 months]

    Data on the changes in healthcare use will be collected from medical records

Secondary Outcome Measures

  1. Clinical impact and acceptability [12 months post initiation of hypoallergenic formula containing synbiotics]

    Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Months to 13 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Aged <13 months

  • Confirmed or suspected CMA- based on healthcare professional (HCP) judgement

  • At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding

  • Recently prescribed a hypoallergenic formula containing synbiotics

Exclusion Criteria:

  • Exclusively breastfed infants

  • Primary lactose intolerance

  • Enterally fed infants

  • Premature infants (born <37 weeks) with a corrected age of less than 1 month

  • Infants with contraindications to the use of hyopallergenic formula containing synbiotics

  • Major hepatic or renal dysfunction

  • Investigator concern around the ability of family to comply with protocol and requirements of study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adam Practice Poole United Kingdom

Sponsors and Collaborators

  • Nutricia UK Ltd

Investigators

  • Study Director: Medical Director, Nutricia UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nutricia UK Ltd
ClinicalTrials.gov Identifier:
NCT05046418
Other Study ID Numbers:
  • HAFSYN21
First Posted:
Sep 16, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nutricia UK Ltd
synbiotics
paediatrics
gut microbiome
Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity

Study Results

No Results Posted as of Mar 11, 2022