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The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.
Dietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.
Literature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| α-galactosidase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| α-galactosidase | Dietary Supplement | Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children < 20kg: 4 drops; children > 20kg and < 40kg: 8 drops; children > 40kg: 1 tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Global distress associated with gas-related symptoms (bloating, flatulance, abdominal distension and abdominal spasm): data collected by parents or patients on a daily diary chart, 3 time/daily by using a validated visual score scale (Faces Pain Scale-Revised). | 5 weeks of observation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical tolerability | Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment | treatment: 2 weeks |
| Efficacy | Frequency and intensity (6 point scale: 0=absent; 5=very severe)of bloating, flatulance, visible distension, spasms. Data were collected by parents or patients on a daily diary chart. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24063420 | Derived | Di Nardo G, Oliva S, Ferrari F, Mallardo S, Barbara G, Cremon C, Aloi M, Cucchiara S. Efficacy and tolerability of alpha-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013 Sep 24;13:142. doi: 10.1186/1471-230X-13-142. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D005414 | Flatulence |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Placebo | Dietary Supplement | Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children < 20kg: 4 drops; children > 20kg and < 40kg: 8 drops; children > 40kg: 1 tablet. |
|
| 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) |
| Efficacy | Physician's overall evaluation: 4 point scale (from completed/marked improvement to worse). | 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |