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| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MS-11-0203 | Other Identifier | University of Texas Health Science Center at Houston |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri | Active Comparator | The first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.) |
|
| Sunflower Oil | Placebo Comparator | The second arm includes 15 subjects on placebo (sunflower oil.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status. |
| 92 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 42 & 92 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri. | Clinical scoring of crying and fussing will be evaluated using the Barr diary which will show crying patterns. | 92 days |
| Determine effects of L. reuteri in 45 healthy infants with colic measuring the immunologic responses with plasma cytokines and circulating regulatory T-cells. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Marc Rhoads, M.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28969890 | Result | 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. | |
| 30177353 |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D003448 | Crying |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009633 | Nonverbal Communication |
| D003142 | Communication |
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|
| Placebo | Biological | Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above. |
|
|
| 1& 42 days |
| Determine effect of L. reuteri on gastrointestinal inflammation as assessed by fecal microbiota in 45 healthy infants with colic. | A stool sample will be collected and analyzed to determine the effect on overall microbiota produced by the ingestion of LR. | 1, 42 & 92 days |
| Derived |
| Rhoads 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. |
| D001519 | Behavior |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |