Digestive System Gut Flora and fauna
Conditions
Interventions
Sucredulcor (Saccharine)
Sponsors
Centre de Recherches Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital Lambaréné, Gabon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ 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)
Exclusion criteria
Exclusion criteria: ¿ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microscopic faecal parasite eggs counts of intestinal helminths will be determined at day 0 and day 30 using Kato-Katz faecal thick smear exams (eggs per gram of faeces). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Microscopic faecal parasite eggs count of intestinal helminths will be determined at the following time points: day 7, day 14,90, 120 and 180 ;- Safety profile of gut flora depletion based on adverse events collection through the study period-frequency and severity of adverse events (AEs) and serious AEs.;- Sub-microscopic RT-PCR-based parasite eggs count of intestinal helminths will be determined at the following time points: days 0, 7, 14 30 and 90, 120 (table 1) - Metabolomics changes at day 30, 90, 120, 180. ;- Metabolomics changes at day 30, 90, 120, 180;- Identification and quantification of gut flora colonies based on quantification of the 16S rRNA gene prior antibiotic administration and at days 7, 14, 30, and 90, 120 and 180;Assessing peripheral circulating cytokine levels regardless the source: IL-17A, IL-17F, IL-22;- Pattern of peripheral lymphocytes producing cytokines including (a) T-lymphocytes: Th1 (INF¿, TNF¿), Th2 ( IL-4, IL-13), Th17 (IL-17A, IL-6, IL-21), Treg (Foxp3, IL-10, TGFß) (b) B-lymphocytes (IL-6, IL-8, IL-17A, IL-17F, IL-10) and (c) ILCs: ILC3 (IL-17, IL-22, GM-CSF) | — |
Countries
Gabon
Contacts
Public ContactSelidji Agnandji Todagbe
Centre de Rcherches Medicales de Lambarene-Gabon
Outcome results
None listed