|- candidate number||14834|
|- NTR Number||NTR3979|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mei-2013|
|- Secondary IDs||NEO.1.C.F |
|- Public Title||An Amino Acid based Formula with synbiotics: Effects on gut microbiota and stool characteristics in suspected gastrointestinal non-IgE mediated Cow’s Milk Allergy (ASSIGN I).|
|- Scientific Title||A randomised, double-blind, controlled study to assess the effect of an Amino Acid based Formula with a synbiotic blend on gut microbiota and stool characteristics in infants with suspected gastrointestinal non-IgE mediated Cow’s Milk Allergy.|
|- ACRONYM||ASSIGN I|
|- hypothesis||To assess the effect of an Amino Acid based Formula (AAF) with synbiotics on the bacterial composition of faecal samples (counts of Bifidobacteria by using fluorescence in situ hybridization (FISH)) of infants with suspected gastrointestinal non-IgE mediated Cow’s Milk Allergy (CMA) compared to an AAF without synbiotics. |
|- Healt Condition(s) or Problem(s) studied||Cow's milk allergy|
|- Inclusion criteria||1. Infants <13 months of age i.e. up to and including the day before the infant is 13 months of age;|
2. Clinical history or strong suspicion of a reaction to cow’s milk protein AND at least one of the following (gastrointestinal) symptoms:
A. Poor weight gain;
B. Frequent regurgitation or vomiting;
C. Extended periods of diarrhoea with negative culture;
D. Constipation (with/without perianal rash);
E. Blood in stool;
F. Iron deficiency anaemia due to occult or macroscopic blood loss in stools;
G. Feeding difficulties/refusal other than behavioural disorders or food (neo)phobia;
H. Endoscopically confirmed enteropathy;
I. Persistent distress or colic (> 3 hours per day at least 3 days a week over 3 week period).
3. Negative result on Specific IgE test (RAST) for cow’s milk protein AND/OR negative result on skin prick test for cow’s milk in case test has previously been performed;
4. Expected minimum product intake (per day) at the end of week 2 of:
A. Birth up to 6 months: 500ml;
B. From 6 months to 8 months: 450ml;
C. From 9 months onwards: 350ml;
5. Written informed consent provided by parents/ guardians, according to local law.
|- Exclusion criteria||1. Infants less than 2500 g at birth;|
2. Infants less than 37 weeks gestation who require specific premature formula at the time of study entry;
3. Infants with severe concurrent illness;
4. Infants who present with functional gastrointestinal symptoms where atopy and food allergy is not suspected;
5. Infants with immune or autoimmune gut enteropathy;
6. Behavioural disorders with food aversion or food phobia;
7. Infants who have undergone gastrointestinal surgery such as bowel resection or stoma placement;
8. Infants with Down syndrome or other syndromes where functional gastrointestinal disorders are common;
9. Use of probiotic bacteria or probiotic containing drinks/supplements in the 4 weeks preceding study entry and during the study;
10. Use of systemic antibiotics or anti-mycotic drugs 4 weeks preceding study entry and during the study;
11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
12. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-mei-2013|
|- planned closingdate||30-jun-2013|
|- Target number of participants||68|
|- Interventions||Duration of intervention: 8 weeks;|
Intervention group: AAF with prebiotics and probiotics (synbiotics) formulation;
Control group: AAF without synbiotics.
|- Primary outcome||To assess the effect of an Amino Acid based Formula (AAF) with synbiotics on the bacterial composition of faecal samples (counts of Bifidobacteria by using fluorescence in situ hybridization (FISH)) of infants with suspected gastrointestinal non-IgE mediated Cow’s Milk Allergy (CMA) compared to an AAF without synbiotics. |
|- Secondary outcome||To assess the effects of an AAF with synbiotics compared to an AAF without synbiotics with respect to:|
1. Stool characteristics in terms of colour, frequency and consistency;
2. Parameters of gut health and immune status:
A. Faecal secretory IgA;
B. Faecal concentrations of Short Chain Fatty Acids (SCFA); butyrate, propionate and acetate.
|- Timepoints||1. Screening;|
3. Week 8.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Reina den Hollander|
|- CONTACT for SCIENTIFIC QUERIES|| Reina den Hollander|
|- Sponsor/Initiator ||Nutricia Research – Centre for Specialised Nutrition|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief summary||This study is initiated to evaluate the effect on the microbiota composition of stool samples, benefits on stool characteristics and clinical effects of an elimination diet using an amino acid formula with an added pre-probiotic blend in infants with Cow’s Milk Allergy. The parents/guardians of infants with a clinical history of a reaction or a suspected non-IgE mediated allergy to cow’s milk protein will be provided with information about the study by the investigating centre and invited to take part. The subjects will be screened for in- and exclusion criteria at the screening visit (V1). During the screening visit, data on the medical history, subject’s characteristics, medications used and feeding history will be collected. |
At the baseline visit (V2) clinical assessments of allergic symptoms (will be carried out and a saliva sample and stool sample will be collected. If the stool sample collection is not possible during the visit, a stool sampling kit and instructions will be given to collect the stool sample at home. For the stool sample collection during the week 8, the stool sampling kit will be given to the parents at V2 to collect the stool sample at home.
The parents/guardians will be provided with study product and parent diary and advised on use of the study product and on completion of the parent diary. Parents/guardians of subjects will be asked about acceptance and tolerance of formula.
Subjects will take their study product for a total of eight weeks with a final visit (V3) at week 8. At this final visit clinical assessment of allergic symptoms will be carried out using the clinician rating scales. Anthropometric measurements will be repeated and parent diaries and the frozen stool sample(s) will be provided by parents/guardians to the centre. A saliva sample will be collected during V3.
|- Main changes (audit trail)|
|- RECORD||1-mei-2013 - 8-okt-2013|