Wild-Type Quailes Strain Salmonella Typhi: Quailes Typhoid toxin knock out strain in a 1:1 ratio at a dose of 1-5 x 10^4CFU
All participants will receive the same intervention in a given group for challenge (dose reduction may occur for later participants depending on the results from the first six participants)

Salmonella Typhi Infection

The challenge agents will be delivered in 30 ml of sodium bicarbonate solution, preceded by 120 ml of solution of sodium bicarbonate to neutralise gastric acid.

Salmonella Typhi challenge

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Understanding How Salmonella Typhi Infects Humans (Bottlenecks)

Exploring the Bottleneck Hypothesis of the Pathogenesis of Bacteraemia in an Ambulatory Outpatient Human Experimental Infection of Salmonella Typhi

Number of participants with a bacteraemia caused by wild-type S. Typhi or Typhoid toxin knock-out strain or a combination of both strains as assessed by identification of strains isolated from blood cultures

Number of isolates that are wild-type S.Typhi or Typhoid toxin knock-out strain obtained using quantitative blood cultures

Number of participants with positive stool cultures caused by wild-type S. Typhi or Typhoid toxin knock-out strain or a combination of both strains as assessed by identification of strains isolated from stool cultures

Number of participants with a bacteraemia caused by wild-type S. Typhi or Typhoid toxin knock-out strain or a combination of both strains as assessed by identification of strains isolated from blood cultures (obtained at less than 72 hours post challenge)

To count what proportion of stool culture isolates are wild-type S.Typhi or Typhoid toxin knock-out strain obtained using quantitative stool cultures

Number of responses obtained from each recruitment method used and number of responses which translated into participants. Number of participants excluded and reasons for exclusion.

Direct access will be granted to authorised representatives from the Sponsor and host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections.

University of Oxford

Ambulatory outpatient human experimental infection

Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a freeze dried powder (20 gm thrice a day) for 4 weeks.
+ Antibiotics + Diuretics +Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated

Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Placebo (Pasteurised Milk Powder) 20 gms thrice a day for 4 weeks
+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated.

Alcoholic Hepatitis

Bovine Colostrum

Placebo

Department of Gastroenterology, D.M.C. and Hospital

Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial

Change in mDF levels will be measured at baseline and after 30 days of treatment

Change in Endotoxin levels will be measured at baseline and after 4 weeks of treatment

Change in Cytokines levels will be measured at baseline and after 30 days of treatment

Number of episodes of sepsis (bacteremia, Pneumonia, SBP, Cellulitis, UTI)

Prof. Sandeep S Sidhu

Prof. Sandeep Singh Sidhu

Dayanand Medical College and Hospital

Bacterial Meningitis

glycerol by mouth (po) 1.5ml/kg max 25 ml/dose x 6 hourly x 8 doses
paracetamol PR 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7

Glycerol and paracetamol

paracetamol 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses

Paracetamol

paracetamol po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository

po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository

35 mg/kg po first dose, then 20 mg/kg 6 hourly x 7 paracetamol
1.5 ml/kg max 25 ml/dose 6 hourly x 8 doses

Paracetamol and glycerol

glycerol 1.5 ml/kg /dose 6 hourly x 8 max dose = 25ml

Glycerol

College of Medicine, Queen Elizabeth Central Hospital

Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis

Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis - A Prospective, Randomized, and Double-Blind Clinical Study Using a Two-by-Two Factorial Design

bacteremia/glavobolja

Understanding How Salmonella Typhi Infects Humans (Bottlenecks)

Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial

Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis

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