GastrointestinalPhase 1NCT01849991
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
A Phase 1 study testing Lactobacillus reuteri in people with Gastrointestinal and Colic, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic. Read more about this study
- Who is it for?
- Ages 3 weeks to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Colic
- What is being tested?
- Lactobacillus reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2016
- Phase
- Phase 1
- 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 weeks to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term babies with colic (21-90 days old, who cry/fuss > 3h daily x > 3d wk)
- baby must have more than 3h crying for enrollment
Who cannot join
- severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis)
- failure to thrive
- intrauterine growth retardation
- hematochezia (blood in the stools)
- diarrhea (watery stools that takes the shape of a container > 5x daily)
- fever (38.2 degrees)
- Premature infants (<37 wk gestation)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
Read the detailed description
This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.
Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.
- Conditions
- Gastrointestinal, Colic
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- Crying, Fussiness, Gas, Hydrogen Breath, Fecal Calprotectin
- Medical subject headings
- Colic, Crying, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriBiological
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment.
The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.
PlaceboBiological
Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri | Active comparator | The first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.) Receives: Biological: Lactobacillus reuteri |
| Sunflower Oil | Placebo comparator | The second arm includes 15 subjects on placebo (sunflower oil.) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.
- Physical Examination of infants will be performed to evaluate any adverse effects of LR.
- Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.
Measured: 92 days
Secondary outcomes (1)
Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.
To examine for evidence of anti-inflammatory effects in the normal intestine, we will test fecal samples from all infants for calprotectin level.
Measured: 1, 42 & 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastrointestinalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Marc Rhoads, The University of Texas Health Science Center, Houston
- Investigators
- J. Marc Rhoads, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849991
- Sponsor's protocol ID
- HSC-11-0203
- Other IDs
- HSC-MS-11-0203
- Status last verified
- Jan 2018
- First submitted
- 31 Jan 2013
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fatheree NY, Liu Y, Taylor CM, Hoang TK, Cai C, Rahbar MH, Hessabi M, Ferris M, McMurtry V, Wong C, Vu T, Dancsak T, Wang T, Gleason W, Bandla V, Navarro F, Tran DQ, Rhoads JM. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017 Dec;191:170-178.e2. doi: 10.1016/j.jpeds.2017.07.036. Epub 2017 Sep 29.
PubMed 28969890Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
PubMed 30177353
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
- ClinicalTrials.gov ID
- NCT01849991
- Acronym / sponsor ID
- HSC-11-0203
- Conditions
- Gastrointestinal, Colic
- Keywords
- Crying, Fussiness, Gas, Hydrogen Breath, Fecal Calprotectin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 May 2013 (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 protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
Detailed description
This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.
Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri | Active comparator | Biological: Lactobacillus reuteriThe first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.) |
| Sunflower Oil | Placebo comparator | Biological: PlaceboThe second arm includes 15 subjects on placebo (sunflower oil.) |
Who may qualify
- Ages
- 3 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full-term babies with colic (21-90 days old, who cry/fuss > 3h daily x > 3d wk)
- baby must have more than 3h crying for enrollment
Key exclusion criteria (7 listed)
- severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis)
- failure to thrive
- intrauterine growth retardation
- hematochezia (blood in the stools)
- diarrhea (watery stools that takes the shape of a container > 5x daily)
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 reuteriLactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily. | Biological | Lactobacillus reuteri |
| PlaceboPlacebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above. | Biological | Sunflower Oil |
Primary outcome
45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status.
Time frame: 92 days
1. Physical Examination of infants will be performed to evaluate any adverse effects of LR. 2. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects.
1 secondary outcome
Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin.
Time frame: 1, 42 & 92 days
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 30 Jan 2018.
- Results publication: PubMed 28969890Fatheree NY, Liu Y, Taylor CM, Hoang TK, Cai C, Rahbar MH, Hessabi M, Ferris M, McMurtry V, Wong C, Vu T, Dancsak T, Wang T, Gleason W, Bandla V, Navarro F, Tran DQ, Rhoads JM. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017 Dec;191:170-178.e2. doi: 10.1016/j.jpeds.2017.07.036. Epub 2017 Sep 29.
- Derived from this study: PubMed 30177353Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
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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.
J. Marc Rhoads, M.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus reuteri in people with Gastrointestinal and Colic, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 7 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status. (time frame: 92 days). 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 NCT01849991, which also lists 2 linked publications.
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 30 Jan 2018.