Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn

Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn

This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in postprandial heartburn.

The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.

Inclusion Criteria:

• Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the study (at least 2 times a week)
• Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
• Written informed consent is a prerequisite for subject enrollment.

Exclusion Criteria:

• Gastrointestinal bleeding within 12 months prior to the study
• Difficulty swallowing (dysphagia)
• History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
• Participation in other studies within the last 30 days prior to entry or during the study