Minor Digestive DisordersNCT01235884
Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation
A study testing Lactobacillus reuteri in people with Minor Digestive Disorders, run by University of Bari at 8 sites in Italy.
Trial summary
Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation. Study Design. Double blind, randomized, controlled, multicenter study. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Minor Digestive Disorders
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 492 participants
- Where
- 8 sitesItaly
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neonates of 37-42 week gestational age and appropriate birth weight
- Recruitment age: until 7 days of life
- Informed consent signed
Who cannot join
- Presence of other gastrointestinal diseases.
- Use of FANS, aspirin or other drugs
- Use of antibiotics and/or PPIs e/o anti-H2
- Participation to other clinical trials
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
University of Bari
Bari, BA, 70124
Ospedale Sant'Orsola Malpighi
Bologna, BO
Ospedale Civile
Crotone, KR
Arcispedale S. Anna
Ferrara, FE
Ospedale di Sesto S. Giovanni
Milan, MI
Policlinico "S. Matteo"
Pavia
Ospedale "Frà Castoro"
San Bonifacio, VR
Ospedale "SS. Annunziata"
Taranto, TA
About this study
Official title: Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.
Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation.
Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days.
Read more
After the inclusion, at baseline will be performed :
- Paediatric visit
- antropometric valutation
- number of the daily crying minutes, number of regurgitation and number of daily evacuation
The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:
- Paediatric visit
- antropometric valutation
- number of daily crying minutes
- numbers of regurgitation
- numbers of evacuations
Primary outcome :
To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation.
Inclusion criteria
- neonates of 37-42 week gestational age and appropriate birth weight
- Recruitment age: until 7 days of life
- Informed consent signed
Exclusion criteria
- Presence of other gastrointestinal diseases.
- Use of FANS, aspirin or other drugs
- Use of antibiotics and/or PPIs e/o anti-H2
- Participation to other clinical trials
- Conditions
- Minor Digestive Disorders
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- gaseous colic, regurgitation and of constipation
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
1000000000 CFU per day (5 drops) for 28 days
PlaceboDietary supplement
5 drops daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri | Active comparator | Dietary Supplement Receives: Dietary Supplement: Lactobacillus reuteri |
| Placebo | Placebo comparator | Dietary Supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the onset of gaseous colic, regurgitation and of constipation.
After the inclusion, at baseline will be performed :
- Paediatric visit
- antropometric valutation
- number of the daily crying minutes, number of regurgitation and number of daily evacuation
The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:
- Paediatric visit
- antropometric valutation
- number of daily crying minutes
- numbers of regurgitation
- numbers of evacuations
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minor Digestive DisordersStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Indrio, University of Bari
- Investigators
- Flavia Indrio, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235884
- Sponsor's protocol ID
- FI-RF-01/10
- Status last verified
- Feb 2013
- First submitted
- 5 Nov 2010
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.
PubMed 24424513
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.
- ClinicalTrials.gov ID
- NCT01235884
- Acronym / sponsor ID
- FI-RF-01/10
- Conditions
- Minor Digestive Disorders
- Keywords
- gaseous colic, regurgitation and of constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Nov 2010 (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.
Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation.
Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days.
After the inclusion, at baseline will be performed :
- Paediatric visit
- antropometric valutation
- number of the daily crying minutes, number of regurgitation and number of daily evacuation
The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses:
- Paediatric visit
- antropometric valutation
- number of daily crying minutes
- numbers of regurgitation
- numbers of evacuations
Primary outcome :
To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation.
Inclusion criteria
- neonates of 37-42 week gestational age and appropriate birth weight
- Recruitment age: until 7 days of life
- Informed consent signed
Exclusion criteria
- Presence of other gastrointestinal diseases.
- Use of FANS, aspirin or other drugs
- Use of antibiotics and/or PPIs e/o anti-H2
- Participation to other clinical trials
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri | Active comparator | Dietary Supplement: Lactobacillus reuteriDietary Supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- neonates of 37-42 week gestational age and appropriate birth weight
- Recruitment age: until 7 days of life
- Informed consent signed
Key exclusion criteria (4 listed)
- Presence of other gastrointestinal diseases.
- Use of FANS, aspirin or other drugs
- Use of antibiotics and/or PPIs e/o anti-H2
- Participation to other clinical trials
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 |
|---|---|---|
| Lactobacillus reuteri1000000000 CFU per day (5 drops) for 28 days | Dietary supplement | Lactobacillus reuteri |
| Placebo5 drops daily for 28 days | Dietary supplement | Placebo |
Primary outcome
Reduction of the onset of gaseous colic, regurgitation and of constipation.
Time frame: one year
After the inclusion, at baseline will be performed : * Paediatric visit * antropometric valutation * number of the daily crying minutes, number of regurgitation and number of daily evacuation The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses: * Paediatric visit * antropometric valutation * number of daily crying minutes * numbers of regurgitation * numbers of evacuations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Derived from this study: PubMed 24424513Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.
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.
Flavia Indrio, MD principal investigator
University of Bari
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri in people with Minor Digestive Disorders, run by University of Bari at 8 sites in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the onset of gaseous colic, regurgitation and of constipation. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235884, which also lists 1 linked publication.
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 5 Feb 2013.