Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study.
Ovidiu Burta, Claudia Iacobescu, Radu Bogdan Mateescu, Tudor Nicolaie, Nicoleta Tiuca, Corina Silvia Pop · Translational gastroenterology and hepatology · 2018
Research-use notice
Independent study record
Each H2HUBB study page organizes source-linked research details for educational use. Interpretation should remain proportional to the study design, population, controls, and limitations.
H2HUBB TAKEAWAY
In with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional g, at Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms. These findings add human evidence that helps define the outcomes that did and did not change with molecular hydrogen in this study.
What the Findings Mean
H2HUBB reviewed how molecular hydrogen affected the outcomes measured in with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional g. At Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms.
What the Researchers Studied
The researchers studied with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional g. The study used a randomized, double-blind human clinical trial.
What Effects Did Molecular Hydrogen Have?
Subjects who met any of the following criteria were not eligible for study admission: pregnant or breastfeeding women; allergy to one of the product ingredients; impossibility to attend study visits; health status not allowing study participation; diabetic patients; patients treated with antibiotics or those using purgatives within two weeks prior to the hydrogen breath test. At Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms. The authors concluded that both APT036 and simethicone had good safety profiles but APT036 was superior to simethicone in relieving symptoms of functional bloating.
Why These Findings Matter
This publication adds useful evidence about where molecular hydrogen did and did not change the measured outcomes, helping define the larger therapeutic evidence base.
How Strong Is This Evidence?
This is human clinical evidence from a randomized, double-blind human clinical trial. H2HUBB interprets the findings in the context of the study design, sample, comparator, and measured outcomes rather than using one publication as a verdict on hydrogen therapy.
Technical Study Details
H2HUBB classifies this publication as human clinical study with human clinical evidence. The research population or model was with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional g. The reported sample size was 108. The study used a randomized, double-blind human clinical trial.
Limitations and Safety
Reported limitations: A major limitation of randomized clinical trials is their restriction to interventions that are meant to have a positive treatment effect. Another limitation relates to the difficulty in interpreting or generalizing the results because the studied population is not wholly representative of the population treated in usual practice.
Original Study and H2HUBB Research Context
H2HUBB presents this source-grounded research record as one contribution to the broader molecular-hydrogen evidence base. The original scholarly source is available at https://tgh.amegroups.org/article/view/4577/5354.