Colostrum high protein powder (Neovite) given orally or through NG tube 1.5g daily, in addition to standard care following WHO guidelines for management of SAM.

N-Acetyl glucosamine (GInNAC). Given orally (1g three times daily) for 14 days, gradually increased from 0.5g to avoid osmotic diarrhoea, in addition to standard care following WHO guidelines for management of SAM.

Teduglutide s/c. Administration by subcutaneous injection (0.5mg/kg/day) daily for 14 days, in addition to standard care following WHO guidelines for management of SAM.

Budesonide 3mg orally daily for 14 days, then rapidly tapered, in addition to standard care following WHO guidelines for management of SAM.

Standard care following WHO guidelines for management of SAM.

Severe Acute Malnutrition

Bovine colostrum provided as powder will be reconstituted and administered orally or via NG tube.

Colostrum high protein powder (Neovite)

N-Acetyl glucosamine provided as powder will be reconstituted and administered orally or via NG tube.

N-Acetyl Glucosamine (GInNAC)

Teduglutide will be administered daily as subcutaneous injection

Teduglutide

Budesonide liquid (as marketed for nebulisation) will be administered orally or bia NG tube daily.

Budesonide

University Teaching Hospital, Nationalist Road

Harare Central Hospital

Parirenyatwa Hospital

Therapeutic Approaches to Malnutrition Enteropathy

Therapeutic Approaches to Malnutrition Enteropathy: Phase II Trials of Four Novel Interventions in Children in Zambia and Zimbabwe

Composite measure of concentration of three faecal inflammatory markers (myeloperoxidase, neopterin, alpha1-antitrypsin) measured by ELISA

Lactulose:rhamnose ratio of concentration in urine samples collected over 2 hours following oral administration of test dose

Plasma LPS concentration measured by limulus amoebacyte lysate assay

Plasma LBP concentration measured by ELISA

Plasma FABP concentration measured by ELISA

Plasma concentration of soluble CD14 measured by ELISA

Plasma concentration of CD163 measured by ELISA

Plasma concentration of C-reactive protein measured by ELISA

Plasma concentration of albumin measured by ELISA

Stool concentration of REG-1 beta measured by ELISA

Number of deaths in each treatment allocation group

Number of adverse events in each treatment allocation group

Change in weight and length measured by experienced nurses and expressed as change in weight-for-length z score compared to WHO standard

Number of days during which diarrhoea was experienced assessed by experienced nurses

xv. Days with fever (two or more recordings of core temperature of 37.8oC or higher in any 24 h period)

Change in villus height and crypt depth measured in endoscopic biopsies (Lusaka only)

Leakage of fluorescein into gut lumen assessed by Watson score during confocal laser endomicroscopy (Lusaka only)

Queen Mary University of London

The active substance used in the T-ChOS capsule formulation is a chitooligosaccharide blend.

Advanced Solid Tumors

T-ChOS 600 mg (two capsules, each 300 mg) daily in the morning 30 minutes before food.

T-ChOS

Herlev & Gentofte University Hospital, Denmark

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

• time to reach maximum plasma concentration (tmax)

• area under the plasma concentration-time curve from zero to the last measurable time point (AUC0-t)

• area under the plasma concentration-time curve from zero to infinity (AUC)

• apparent plasma clearance following oral administration (CL/F)

Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

ORR = complete response + partial response, according to RECIST 1.1

DCR = complete response + partial response + stable disease, according to RECIST 1.1

n acetyl glucosamine/zápal

Therapeutic Approaches to Malnutrition Enteropathy

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

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