EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03357237
• Date of registration: 24/11/2017
• Prospective Registration: Yes
• Primary sponsor: Enriqueta Roamn
• Public title: EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN PEDXIL01
• Scientific title: RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
• Date of first enrolment: December 1, 2017
• Target sample size: 120
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03357237
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Enriqueta Roman, PHD
• Affiliation: Hospital Universitario Puerta de Hierro Majadahonda

• Name: Maria Jose Garcia, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or
liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or
increase in the number of stools (greater or equal to 3 / day) with a duration of less
than 72 h

- Age over 3 months and under 5 years

- Written informed consent according to ICH / GCP and local legislation, obtained before
any study procedure of parents or guardians

Exclusion Criteria:

- Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite,
probiotics or zinc (including oral rehydration solution containing zinc and / or
probiotics) in the previous week

- Exclusive breastfeeding

- Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel
disease, food allergy)

- Immunodeficiencies

- Malnutrition (weight / height / length less than P3 according to WHO standards)

- Severe dehydration

- Impossibility of follow-up

- Known hypersensitivity to gelatin or xyloglucan

- Absence of informed consent

- Caregivers / parents who can not understand or comply with all the instructions and
requirements of the study.

- If in the opinion of the researcher there are findings in the physical examination,
abnormalities in the results of the clinical analyzes or other medical, social or
psychosocial factors that could negatively influence



Age minimum: 3 Months
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diarrhea

Intervention(s)

Other: medical device

Primary Outcome(s)

time of resolution of diarrhea [Time Frame: 14 days]

Secondary ID(s)

PEDXIL 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors