NCT06830681

Terminated

CMPA-GO Study: Growth and Safety Outcomes in Infants With CM...

Société des Produits Nestlé (SPN)Source

Société des Produits Nestlé (SPN)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2317.CLI

Study Type

interventional

Actual enrollment (reported)

4

Locations

1 country

Sites

1

Timeline

Study Start

January 7, 2025

Actual (reported)

Primary Completion

May 23, 2025

Actual (reported)

Study Completion

June 23, 2025

Actual (reported)

Brief Summary

CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 4 participants
Study completion date: June 23, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 7, 2025
Actual (reported)
First Submitted
January 15, 2025
Actual (reported)
First Posted
February 17, 2025
Actual (reported)
Primary Completion
May 23, 2025
Actual (reported)
Study Completion
June 23, 2025
Actual (reported)

Last Updated: June 29, 2025
Status Verified: June 2025
Last Update Submitted: June 25, 2025

Conditions

Cow Milk Protein Allergy

Outcome Measures

Primary Outcomes (1)

Growth
To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.
16 weeks

Secondary Outcomes (5)

Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
52 weeks
Tolerability
52 weeks
Growth
52 weeks
Stool frequency and characteristics
52 weeks
Quality of life
52 weeks

Study Arms (2)

Test Formula

EXPERIMENTAL

New generation eHF

Dietary Supplement: New generation eHF

Control Formula

ACTIVE COMPARATOR

Commercial eHF

Dietary Supplement: Commercial eHF

Interventions

New generation eHFDietary supplement

New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.

Test Formula

Commercial eHFDietary supplement

Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.

Control Formula

Eligibility Criteria

Age4 Weeks - 22 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Full term infant (gestational age ≥37 weeks and ≤42 weeks).
Birth weight ≥2500 g and ≤4500 g.

Sponsors & Collaborators

Société des Produits Nestlé (SPN)
Industrylead

Study Sites (1)

Grupo Pediátrico Uncibay

Málaga, Spain

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

February 17, 2025

Study Start

January 7, 2025

Actual (reported)

Not Applicable

Not Yet Recruiting

NCT07687797

Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance

Not ApplicableNot Yet Recruiting

NCT06998225

Tolerance to Baked Goods in Allergic Children

Not ApplicableCompleted

NCT07242950

Effect of Elimination Diet on Intestinal Mucus Barrier in Infants With Cow's Milk Protein Allergy

Completed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Infant aged ≥29 days (\>4 weeks) and \<5 months (≤22 weeks).

Not breastfed at time of Screening Visit.

History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.

You may not qualify if:

Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
Demonstrated chronic malabsorption not due to CMPA.
History of anaphylaxis to CMP.
Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
History of any immunotherapy for CMPA.
Past or current disease or disorder which, in the opinion of the Investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the subject's ability to participate in the study.

Contact the study team to confirm eligibility.

Primary Completion

May 23, 2025

Actual (reported)

Study Completion

June 23, 2025

Actual (reported)

Last Updated

June 29, 2025

Record last verified: 2025-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06830681
Data provider: ClinicalTrials.gov
Source updated: 2025-06-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:57 UTC

Locations

ES(1)

Study Stopped

CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Test Formula

Control Formula

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Test Formula

Control Formula

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations