---
title: "An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy"
nct_id: NCT01109966
overall_status: TERMINATED
phase: NA
sponsor: Nutricia Research
study_type: INTERVENTIONAL
primary_condition: Allergy
countries: France, Germany, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01109966.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01109966"
ct_last_update_post_date: 2017-05-08
last_seen_at: "2026-05-12T06:22:19.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

**Official Title:** A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)

**NCT ID:** [NCT01109966](https://clinicaltrials.gov/study/NCT01109966)

## Key Facts

- **Status:** TERMINATED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 34
- **Lead Sponsor:** Nutricia Research
- **Conditions:** Allergy, Food Allergy
- **Start Date:** 2010-06
- **Completion Date:** 2012-10
- **CT.gov Last Update:** 2017-05-08

## Brief Summary

The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

## Detailed Description

Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

## Eligibility

- **Maximum age:** 8 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Infants ≤ 8 months of age
* Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months

Exclusion Criteria:

* Infants less than 2500 g at birth
* Infants less than 37 weeks gestation
* Infants with severe concurrent illness
* Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
* Infants consuming less than 500ml per day of their usual formula at study entry
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
```

## Arms

- **Amino acid based formula** (ACTIVE_COMPARATOR) — Patients will be randomised to one of two arms:

Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula
- **New amino acid based formula** (ACTIVE_COMPARATOR) — Patients will be randomised to one of two arms:

Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula

## Interventions

- **Special Medical Food** (OTHER) — Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.

Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age.
- **Special Medical Food** (OTHER) — Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.

Infants should typically consume the following amounts of formula during the study \> 500mls/day up to 12 months of age \> 400mls/day between 12 and 18 months of age \> 300mls/day over 18 months of age.

## Primary Outcomes

- **To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.** _(time frame: 2 years)_

## Secondary Outcomes

- **To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies** _(time frame: 2 years)_

## Locations (7)

- l'hôpital Necker Enfants malades, Paris, France
- Hospital Charité, Berlin, Germany
- St.-Marien-Hospital, Bonn, Germany
- Southampton General Hospital, Southampton, Hampshire, United Kingdom
- David Hyde Allergy Clinic - St. Mary's hospital, Newport, Isle of Wight, United Kingdom
- Evelina Children's Hospital - St Thomas' Hospital, London, United Kingdom
- Newcastle general hospital, Newcastle upon Tyne, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.l'hôpital necker enfants malades|paris||france` — added _(2026-05-12)_
- `locations.hospital charité|berlin||germany` — added _(2026-05-12)_
- `locations.st.-marien-hospital|bonn||germany` — added _(2026-05-12)_
- `locations.southampton general hospital|southampton|hampshire|united kingdom` — added _(2026-05-12)_
- `locations.david hyde allergy clinic - st. mary's hospital|newport|isle of wight|united kingdom` — added _(2026-05-12)_
- `locations.evelina children's hospital - st thomas' hospital|london||united kingdom` — added _(2026-05-12)_
- `locations.newcastle general hospital|newcastle upon tyne||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01109966.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01109966*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*