Gastric pH (pH Pill) Sub-Study Rationale Sample Clauses

Gastric pH (pH Pill) Sub-Study Rationale. The role of CFTR as a regulator of bicarbonate secretion is an old concept that is being increasingly appreciated in recent years. With the availability of a new minimally invasive tool, we have an extraordinary chance to study gastrointestinal pH in patients with CF in a multicenter manner. CF is associated with pancreatic insufficiency (PI) in the majority of patients, although 10-15% may remain pancreatic sufficient (PS). Although not absolute, patients with CFTR mutations in Classes I-III are more likely to be PI than those with class IV and V mutations.5 CF-PI patients have been shown to have inadequate acid neutralization of the duodenum following direct pancreatic stimulation with intravenous secretin and have been shown to have delayed alkalinization of the proximal duodenum using an ingested diagnostic pill that wirelessly transmits pH data (“pH pill”).6, 7 CF-PS patients do not have overt steatorrhea, but they have abnormal bicarbonate and fluid secretion responses to direct pancreatic stimulation with intravenous secretin.8, 9 A pH pill test will be conducted in a subset of enrolled Cohort 2 and 3 subjects to evaluate whether these gradations in bicarbonate secretion (and thus CFTR function) between CF-PI and CF- PS patients can be detected using an ingestible pH pill.
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