Gas Pain Related Intake
Conditions
Keywords
irritable bowel syndrome (IBS), bloating, abdominal distension, flatulence, α-Galactosidase
Brief summary
The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTα-galactosidase
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Azienda Policlinico Umberto I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.
Exclusion criteria
* suspected episodes of hypersensitivity or allergy; * chronic organic disorders (by clinical history, physical examination, laboratory tests); * use of drug affecting the GI motility during the previous 4 weeks; * inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 5 weeks of observation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical tolerability | treatment: 2 weeks | Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment |
| Efficacy | 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks) | 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. |
Outcome results
None listed