Who is sponsoring NCT03874104?

NCT03874104 is sponsored by Nutricia UK Ltd.

What drugs are being tested in NCT03874104?

Interventions in NCT03874104: Extensively Hydrolysed Formula containing Pre- & Probiotics.

What condition does NCT03874104 study?

NCT03874104 studies Cow Milk Allergy.

Is NCT03874104 still recruiting?

NCT03874104 is currently completed. Last updated 27 November 2023.

Last reviewed 2023-11-27 · How we verify

NCT03874104

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Synbiotic Extensively Hydrolysed Feed Study

Completed NA Last updated 27 November 2023

What this trial tests

NA trial testing Extensively Hydrolysed Formula containing Pre- & Probiotics in Cow Milk Allergy in 35 participants. Completed in 31 July 2023.

Timeline

22 August 2018

Primary endpoint
1 December 2021

31 July 2023

Quick facts

Lead sponsor	Nutricia UK Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	35
Start date	22 August 2018
Primary completion	1 December 2021
Estimated completion	31 July 2023
Sites	8 locations across United Kingdom

Drugs / interventions tested

Extensively Hydrolysed Formula containing Pre- & Probiotics

Conditions studied

Cow Milk Allergy — all drugs for Cow Milk Allergy →

Sponsor

Nutricia UK Ltd

Who can join

Under 13 Months, any sex, with Cow Milk Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged \<13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Synbiotic containing extensively hydrolyzed formula improves gastrointestinal and atopic symptom severity, growth, caregiver quality of life, and hospital-related healthcare use in infants with cow's milk allergy.
Hubbard GP, Atwal K, Graham L, Narayanan S, et al · · 2022 · cited 5× · PMID 35634950 · DOI 10.1002/iid3.636

Verify or expand the search:

Other recruiting trials for Cow Milk Allergy

Currently open trials in the same condition.

NCT06380673 — Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy · NA · recruiting
NCT05785299 — Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy · NA · recruiting
NCT04249973 — Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children · active not recruiting

Other Nutricia UK Ltd trials

Trials by the same sponsor.

NCT06941532 — GMP Powdered Substitutes in PKU and TYR · NA · recruiting
NCT04272736 — PKU Low Calorie Drink Study · NA · withdrawn
NCT05822557 — Bolus Pouch Feed Study · NA · completed
NCT05411848 — 2kcal Tube Feed Study · NA · completed
NCT05269992 — Childrens Real Food Tolerance Study · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03874104 (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 Nutricia UK Ltd
Last refreshed: 27 November 2023

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/NCT03874104.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing