IBS Research and Probiotics
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Subjects were recruited through our database, General Practitioners offices and posting adverts in local newspapers. Subjects underwent an initial phone screen and were asked questions regarding their age, gastrointestinal symptoms, history of mood and stress and previous and current medications. Eligible subjects were scheduled for a screening visit. The study was conducted as outlined in the protocol and in accordance with the ICH Guidelines on Good Clinical Practice, and the declaration of Helsinki. The pilot study was an open label design as outlined below. All volunteers took the investigational product for 8-weeks, followed by an 8-week follow up. Volunteers were screened according to the selection criteria. Subjects were screened in order to identify up to participants, between 18 and 55 years of age, with recurrent abdominal pain/discomfort and mild to moderate stress/ mood status. The study involved visits over a 20-week period. A blood sample was collected at each visit. A urine sample was collected at the screening and baseline visits and upon completion of the intervention. For women of childbearing age, a pregnancy test were performed. A saliva sample was collected on the morning of each visit. Subjects were instructed to avoid brushing teeth or using mouth wash on the morning of the saliva collection. Subjects were provided with a stool collection kit at visits and instructed to collect a sample at home and bring it to the clinic at their next visit.
atlantiaclinicaltrials.com
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