Synbiotics Cohort Study

NCT05046418 | Terminated

• 1 other identifier: HAFSYN21
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cows Milk Allergy

Keywords

synbiotics; paediatrics; gut microbiome

Outcome Measures

Primary Outcomes (1)

• Healthcare use

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

  6 months

Secondary Outcomes (1)

• Clinical impact and acceptability

  12 months post initiation of hypoallergenic formula containing synbiotics

Study Arms (1)

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

Interventions

Hypoallergenic formula containing synbiotics OTHER

An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.

Hypoallergenic formula containing synbiotics

Eligibility Criteria

• Age: 0 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Exclusively or partially formula fed infants with confirmed or suspected CMA who have been prescribed hypoallergenic formula containing synbiotics for the management of CMA as part of clinical care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (1)

Adam Practice

Poole, United Kingdom

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Medical Director

  Nutricia UK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: September 5, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)