Procedures
disruptive symptoms, diarrhea, abdominal pain, vomiting, swallowing difficulties, vertigo, tiredness, headache, nausea,, distended abdomen, rashes
ADVERSE EVENTS, ADVERSE EVENT, MINOR, SWALLOWING DIFFICULTIES
Study persons were seen prior to study start and then on days 1, 10 and 15. At each visit the study persons were examined and questioned about adverse events. All study persons received clindamycin capsules and were prescribed 300 mg three times daily on days 1–7. This was followed by a washout period (days 8 and 9) and treatment with two study capsules, containing microbiota or placebo, twice daily on days 10–14. The study capsules were collected at the hospital, where the first dose was taken under supervision, and then transported home in a cooling box where they were stored in the household freezer until taken.Study persons completed an electronic questionnaire on days 1–28 (daily), 60 and 180. The number of defecations and their Bristol stool chart score were recorded daily. General and gastrointestinal well-being was also graded on a scale of 1 to 10, with 1 being the lowest and 10 being “best possible health for you”. The experience of the treatment was graded 1 to 5 where 1 corresponded to unproblematic experience and 5 was very unpleasant. Symptoms of nausea, diarrhea, tiredness, vomiting, headache, distended abdomen, abdominal pain, vertigo, rashes, and swallowing difficulties were asked for and graded as 0 (no problem), 1 (minor), 2 (moderate, does not impair daily life), 3 (severe, very undesirable, disruptive symptoms) to 4 (serious or potentially life threatening). Possible adverse events were elicited using a modification of the Common Terminology Criteria for Adverse Events version 3.0 [