Study of interactions between intestinal microflora, intestinal macrofauna and antibiotic use in adults living in Lambaréné, Gabon: a phase I randomised participant blinded placebo controlled trial

Centre de Recherches Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital Lambaréné, Gabon0 个研究点目标入组 40 人开始时间: 2017年6月16日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•¿Healthy males or females between the ages of 21 and 40 years
•¿Participants colonized with either Trichuris trichura or Ascaris lumbricoides; or co-infection both within a +/- 25% interval parasite load
•¿Negative for HIV, HBV and HCV serology.
•¿Body mass index between 18 and 30
•¿Ability to understand and provide written informed consent
•¿Willingness to reside within the study area for the entire study duration (6 months)

•¿Pregnancy as determined by a positive urine hCG (if female).
•¿Currently lactating and breast-feeding (if female).
•¿Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies
•¿Serologic positivity for HIV, Hepatitis B or Hepatitis C
•¿History of vertigo, tinnitus or hearing loss
•¿Laboratory evidence of renal disease (serum creatinin greater than 1.25-times the upper reference limit, or more than trace protein or blood on urine dipstick testing).
•¿Body Mass Index greater than or equal to 30 or less than or equal to 18
•¿Vital signs outside of acceptable range at Screening Visit (i.e., blood pressure >160/100, axillary temperature >38°C)
•¿History of active uncontrolled gastrointestinal disorders or diseases
•¿Chronic and or recurrent diarrhoea (diarrhoea defined as ¿ 3 loose stools per day)
•¿Chronic and or recurrent constipation
•¿Use of any of the following drugs within the last 1 months: antibiotics, antifungals, antivirals or antihelminthics (intravenous, intramuscular, or oral)
•¿Any on-going bacteraemia or pathogenic bacteria identified in stool culture
•¿Positive for Schistosoma spp,and S. Stercoralis
•¿Positive for filariasis

发起方

Centre de Recherches Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital Lambaréné, Gabon