Prophylaxis of atopic and allergic manifestations and activation or modulation of the immune system by Pro-Symbioflor® treatment in newborns / small children from atopically pre-disposed parents.
| ISRCTN | ISRCTN60475069 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60475069 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/07/2010
- Registration date
- 15/09/2010
- Last edited
- 13/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ulrich Wahn
Scientific
Scientific
Department of Pediatric Pneumology and Immunology
(Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie)
Charité
Augustenburger Platz 1
Berlin
13353
Germany
| marina.birr@charite.de |
Study information
| Study design | Prospective randomised placebo controlled double blind parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Prophylaxis by Pro-Symbioflor® of atopic and allergic manifestations and activation or modulation of the immune system in newborns / small children from atopically pre-disposed parents. Prospective, randomized, placebo-controlled, double-blind parallel group trial in 632 healthy newborns aged 4 weeks with increased risk for atopic dermatitis with repeated application of Pro-Symbioflor® t.i.d or placebo between 2 and 7 months of age and an observation period until the age of 3 years. |
| Study acronym | PAPS |
| Study objectives | Pro-Symbioflor® is an immunologically active product containing components of a mixture of Escherichia coli (gram negative) and Enterococcus faecalis (gram positive). Pro-Symbioflor® is claimed to be effective as an immunomodulatory acting drug in the primary prevention of atopic dermatitis and other allergic diseases. To prove this, a trial was designed to test for the Verum - Placebo superiority in the preventive efficacy lowering the risk to develop an atopic disease under a 6 months lasting prophylactic treatment with Pro-Symbioflor® in newborns/ small children aged between 4 weeks and 3 years. In addition its immunomodulatory effects were to be studied. Null hypothesis H0: The risk of a manifestation of atopic dermatitis (AD) under treatment verum or placebo is not different. Alternative hypothesis H1: The risk of a manifestation of AD under treatment with verum is twice as low as under placebo. |
| Ethics approval(s) | 1. The independent ethics committee (IEC) at Charité approved on the 2nd of March 2002 (ref: 19/2002) 2. Intermediate evaluation of the study (half of cases completed) was carried out and approval to continue granted on the 21st of October 2005 3. Amendment to the protocol approved on the 7th of March 2007 |
| Health condition(s) or problem(s) studied | Atopic dermatitis |
| Intervention | 1. Intervention group: Pro-Symbioflor® (verum): Bacterial lysate manufactured from 1,5 4,5 x 10E+07 Enterococcus faecalis (DSM 16440) and 1,5 4,5 x 10E+07 Escherichia coli (DSM 17252). 3x5 drops per day for 2 weeks then increased to 3x10 drops per day between 2 and 7 months of age. 2. Control group: Pro-Symbioflor® (placebo): Culture medium without bacteria. 3x5 drops daily, for 2 weeks increased to 3x10 drops daily between 2 and 7 months of age. The total duration of follow up will be 3 years. |
| Intervention type | Other |
| Primary outcome measure | Incidence of atopic dermatitis during the treatment phase between the 4th and 31st life week under the prophylaxis with verum or placebo. |
| Secondary outcome measures | 1. Incidence of atopic dermatitis after treatment and until end of 3 years 2. Time until the first manifestation of an AD 3. Severity of AD at manifestation of an eczema: SCORing Atopic Dermatitis (SCORAD) Score 4. Frequency and time until the appearance as well as severity of allergic/atopic manifestations in the gastrointestinal tract 5. Frequency and until the appearance as well as severity of an allergic/atopic manifestation in the airways 6. Frequency of a sensitization against food allergens 7. Induction / enhancement of a Th1-immune response 8. Toll-like-receptors 9. Safety pharmacological Investigations before and at the end of the treatment as well as the observation period 10. Adverse events |
| Overall study start date | 28/05/2002 |
| Completion date | 19/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 632 |
| Key inclusion criteria | 1. Healthy male and female newborns aged 4 weeks 2. Regularly developed newborns - body weight: ≥ 2500 g; gestational age > 37+0 weeks 3. No relevant illnesses since the birth (except transient Hyperbilirubinemia) 4. Positive atopic anamnesis with at least one parent (atopic dermatitis, bronchial asthma, allergic rhino-conjunctivitis) 5. Written informed consent by the parents as the legal representatives |
| Key exclusion criteria | 1. Diseases that require immunosuppressive therapy (systemic administration of steroids or cyclosporine A) 2. Transfer to an intensive care unit after birth 3. Known immune disturbances or defects (Lymphopenia, Thrombopenia) 4. Concomitant medication or treatment (except for prophylaxis) 5. Inadequate ability or willingness of the parents to communicate or to cooperate 6. Family anamnesis of a congenital deficiency in immune defence |
| Date of first enrolment | 28/05/2002 |
| Date of final enrolment | 19/09/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Pediatric Pneumology and Immunology
Berlin
13353
Germany
13353
Germany
Sponsor information
SymbioPharm GmbH (Germany)
Industry
Industry
Auf den Lüppen 8
Herborn
35745
Germany
| kurt.zimmermann@symbio.de | |
| Website | http://www.symbiopharm.de |
"ROR" |
https://ror.org/03d8m2k26 |
Funders
Funder type
Industry
Symbiopharm GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No |
