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| ID | Type | Description | Link |
|---|---|---|---|
| 4930 | Other Identifier | SMC |
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The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.
Prospective randomized double-blind placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics supplementation | Experimental | Supplementation by probiotics for 4 weeks |
|
| Placebo | Placebo Comparator | Supplementation of placebo for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Daily oral supplementation for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and intensity of abdominal pain | Number of pain episodes and pain intensity based on a visual scale | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| School absenteeism | Number of patients with school absenteeism | Eight weeks |
| Other gastrointestinal symptoms | Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zvi Weizman, MD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | 84101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27156182 | Derived | Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4. |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Placebo administration |
|
|
| Eight weeks |
| Adverse effects related to treatment | Any adverse effects related to the probiotic supplementation | Eight weeks |
| D012817 | Signs and Symptoms, Digestive |
| D019602 |
| Food and Beverages |