Gas Pain Related IntakePhase 4NCT01595932
Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
A Phase 4 study testing α-galactosidase in people with Gas Pain Related Intake, run by Azienda Policlinico Umberto I.
Trial summary
The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Gas Pain Related Intake
- What is being tested?
- α-galactosidase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 4
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.
Who cannot join
- 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.
About this study
Official title: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
Read the 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.
- Conditions
- Gas Pain Related Intake
- Being tested
- α-galactosidase, Placebo
- Keywords
- irritable bowel syndrome (IBS), bloating, abdominal distension, flatulence, α-Galactosidase
- Medical subject headings
- Irritable Bowel Syndrome, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α-galactosidaseDietary supplement
Also called Sinaire
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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| α-galactosidase | Experimental | Not described Receives: Dietary Supplement: α-galactosidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks of observation
Secondary outcomes (3)
Clinical tolerability
Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment
Measured: 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.
Measured: 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).
Measured: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gas Pain Related IntakeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595932
- Sponsor's protocol ID
- α-galactosidase
- Status last verified
- May 2012
- First submitted
- 9 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24063420
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01595932
- Acronym / sponsor ID
- α-galactosidase
- Conditions
- Gas Pain Related Intake
- Keywords
- irritable bowel syndrome (IBS), bloating, abdominal distension, flatulence, α-Galactosidase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 May 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placebo |
| α-galactosidase | Experimental | Dietary Supplement: α-galactosidase |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| α-galactosidaseAlso: SinaireTreatment 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 supplement | α-galactosidase |
| PlaceboTreatment 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 supplement | placebo |
Primary outcome
Efficacy
Time frame: 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).
3 secondary outcomes
Clinical tolerability
Time frame: treatment: 2 weeks
Efficacy
Time frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Efficacy
Time frame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
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 10 May 2012.
- Derived from this study: PubMed 24063420Di 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing α-galactosidase in people with Gas Pain Related Intake, run by Azienda Policlinico Umberto I.
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 1 inclusion and 4 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 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy (time frame: 5 weeks of observation). 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 NCT01595932, which also lists 1 linked publication.
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 10 May 2012.