Infantile DiarrheaPhase 4PIURANCT01469273
Prophylaxis of Gastrointestinal Infections With EcN
A Phase 4 study testing Mutaflor® Suspension in people with Infantile Diarrhea, run by Hospital San Bartolome at 3 sites in Peru.
Trial summary
This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. Read more about this study
- Who is it for?
- Ages 3 hours to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Diarrhea
- What is being tested?
- Mutaflor® Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesPeru
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 hours to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent form signed by the patient's parents or legal guardians.
- Term born infants.
- Age < 2 days
- Gestational age from 38-42 weeks of gestation
- Birth weight from 2500-3750 gr.
- Normal delivery (eutocia)
Who cannot join
- Simultaneous participation in another clinical study
- Consumption of food supplements or medicines containing live micro-organisms or their metabolic products or components during the study
- Other reasons which in the opinion of the investigator provide a reason against the inclusion of the patient in the study.
- Autoimmune disease·Severe sepsis or severe systemic injury
- Immunosuppressive treatment
- Severe co-morbidities diseases of the:
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- Heart
- Liver
- Kidney
- Genetic disease
- Other serious associated diseases, which in the opinion of the investigator, cast a doubt on the implementation of the test according to the study protocol.
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Centro de Salud Los Algarrobos
Piura, Piura
Segundo Montoya, MD, +51 7335 1635
Segundo Montoya, MD
Centro de Salud Materno Inftantil de Castilla (CESAMICA)
Piura, Piura
Luis Luna, MD
Luis Luna, MD
Materno Infantil Santa Rosa
Piura, Piura
Marco Luna, MD
Marco Luna, MD
About this study
Official title: Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle
This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.
Read the detailed description
Newborns (treatment-group E) and infants at the age of 6 months (treatment-group L) shall be treated with 1 x 1 ml ECN-SUSPENSION for 10 days and observed until the age of 12 months.Treatment-group E (newborn) will receive EcN-Suspension on the first 10 days of life and will be observed for the next 12 months. Treatment-group L (infants at the age of 6 months) will receive EcN-Suspension on the first 10 days of their seventh month of life and will be observed for the next 6 months.The corresponding control group will remain untreated and will be observed only for 12 months. According to the hospitals daily routine the inclusion and exclusion criteria will be checked. All newborns meeting the inclusion criteria will be included into the trial. Patients' anamnestic data and general health status are recorded at the initial control.Controls are performed according to the time schedule normally used in the hospital functioning as a trial site. According to this, during each monthly control data on the efficacy and safety are recorded. The final control for assessing the tolerance and efficacy of the trial medication is conducted along with a physical examination after an observation period of 12 months.In this study, diarrhea is defined as increase of stool frequency to >3 watery or loose stools in 24 hours on at least two or more consecutive days.The prophylaxis against gastrointestinal infections with EcN-Suspension is expected to result in a decrease of the number episodes of diarrhea in comparison to the untreated control. The primary efficacy criterion is the number of episodes of diarrhea caused by gastrointestinal infection within the first 12 months.
- Conditions
- Infantile Diarrhea
- Being tested
- Mutaflor® Suspension
- Keywords
- Diarrhea, EcN, E. coli strain Nissle 1917, Gastrointestinal infection, Infant, Newborn, Probiotic drug, Prevention, Prophylaxis
- Medical subject headings
- Diarrhea, Infantile, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutaflor® SuspensionDrug
Also called EcN, Mutaflor, Newborn, Nissle
Application of Mutaflor-Suspension on 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Only observation; observation period: 1 year. |
| Early Treatment group (E) | Experimental | 1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning before feeding/nursing, first application 48h after birth, latest. Observation period: 1 year. Receives: Drug: Mutaflor® Suspension |
| Late Treatment Group (L) | Experimental | 1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning after feeding/nursing, starting on the first day of the 7th month of life. Observation period: 1 year. Receives: Drug: Mutaflor® Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diarrhea episodes
To show superiority of a prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea, compared to an untreated control group
Measured: 12 months / first year of life
Secondary outcomes (1)
Number of days with diarrhea
To show prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea within the first 12 months of life compared to an untreated control group.
Measured: 12 months / first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Bartolome
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
- Responsible party
- Sponsor
- Investigators
- Ruth Bindels, MD, Principal investigator, Hospital San Bartolome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469273
- Sponsor's protocol ID
- MU 0932 BL
- Acronym
- PIURA
- Status last verified
- Nov 2011
- First submitted
- 8 Nov 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle
- ClinicalTrials.gov ID
- NCT01469273
- Acronym / sponsor ID
- PIURA / MU 0932 BL
- Conditions
- Infantile Diarrhea
- Keywords
- Diarrhea, EcN, E. coli strain Nissle 1917, Gastrointestinal infection, Infant, Newborn, Probiotic drug, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Hospital San BartolomeUniversity, hospital or other
- Collaborators
- Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas
- Study start
- Nov 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.
Detailed description
Newborns (treatment-group E) and infants at the age of 6 months (treatment-group L) shall be treated with 1 x 1 ml ECN-SUSPENSION for 10 days and observed until the age of 12 months.Treatment-group E (newborn) will receive EcN-Suspension on the first 10 days of life and will be observed for the next 12 months. Treatment-group L (infants at the age of 6 months) will receive EcN-Suspension on the first 10 days of their seventh month of life and will be observed for the next 6 months.The corresponding control group will remain untreated and will be observed only for 12 months. According to the hospitals daily routine the inclusion and exclusion criteria will be checked. All newborns meeting the inclusion criteria will be included into the trial. Patients' anamnestic data and general health status are recorded at the initial control.Controls are performed according to the time schedule normally used in the hospital functioning as a trial site. According to this, during each monthly control data on the efficacy and safety are recorded. The final control for assessing the tolerance and efficacy of the trial medication is conducted along with a physical examination after an observation period of 12 months.In this study, diarrhea is defined as increase of stool frequency to >3 watery or loose stools in 24 hours on at least two or more consecutive days.The prophylaxis against gastrointestinal infections with EcN-Suspension is expected to result in a decrease of the number episodes of diarrhea in comparison to the untreated control. The primary efficacy criterion is the number of episodes of diarrhea caused by gastrointestinal infection within the first 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Only observation; observation period: 1 year. |
| Early Treatment group (E) | Experimental | Drug: Mutaflor® Suspension1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning before feeding/nursing, first application 48h after birth, latest. Observation period: 1 year. |
| Late Treatment Group (L) | Experimental | Drug: Mutaflor® Suspension1 x 1 ml of EcN suspension/day on 10 consecutive days, application in the morning after feeding/nursing, starting on the first day of the 7th month of life. Observation period: 1 year. |
Who may qualify
- Ages
- 3 hours to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Informed consent form signed by the patient's parents or legal guardians.
- Term born infants.
Key exclusion criteria (11 listed)
- Simultaneous participation in another clinical study
- Consumption of food supplements or medicines containing live micro-organisms or their metabolic products or components during the study
- Other reasons which in the opinion of the investigator provide a reason against the inclusion of the patient in the study.
- Autoimmune disease·Severe sepsis or severe systemic injury
- Immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutaflor® SuspensionAlso: EcN, Mutaflor, Newborn, NissleApplication of Mutaflor-Suspension on 10 consecutive days. | Drug | Early Treatment group (E), Late Treatment Group (L) |
Primary outcome
Number of diarrhea episodes
Time frame: 12 months / first year of life
To show superiority of a prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea, compared to an untreated control group
1 secondary outcome
Number of days with diarrhea
Time frame: 12 months / first year of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Bindels, MD principal investigator
Hospital San Bartolome
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mutaflor® Suspension in people with Infantile Diarrhea, run by Hospital San Bartolome at 3 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delfina Cetraro, MD (+51 1 4245217, finacetrarocardo@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of diarrhea episodes (time frame: 12 months / first year of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.