Evaluating the effects of the traditional wheat product (saviq) on the pattern of changes caused bychemotherapy in the gastrointestinal tract of children with acute lymphoblastic leukemia

Phase 3

• Conditions: Acute Lymphoblastic Leukemia.; Acute lymphoblastic leukemia, in remission; C91.01

• Registration Number: IRCT20220410054474N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Children aged 3-18 years with severe lymphoblastic leukemia treated in the post-consolidation period.

Exclusion Criteria

Severely ill patients
Patients who must be prescribed fasting by physician
Patients with broad-spectrum antibiotics
Patients with active infection
Patients with celiac disease
Those requiring gastrointestinal surgery
Neutropenic patients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of gastrointestinal symptoms. Timepoint: Beginning and end of the intervention; Days 0 and 28. Method of measurement: Pediatrics Quality of Life Questionnaire - gastrointestinal symptoms scales version 3.0.

Secondary Outcome Measures

Name	Time	Method
Quality of life of children - Weight of the child - Blood test (CBC) - Gastrointestinal microbiome - Number of colonies created by the collection of bacteria in the feces. Timepoint: All variables will be measured on day 0 and day 28 after the intervention. Method of measurement: TAPQOL Quality of Life Questionnaire for Preschool Children (1-6 years old) and PedsQL Questionnaire for Quality of Life of Preschool Children- Weight of the child on day 0 and day 28 after the interventionBlood test (CBC) to check for blood factors including WBC Plt Hb RBC on day 0 and day 28 after intervention - Stool test of the child and performing Real-Time PCR to measure and determine the gastrointestinal microbiome on day 0 and day 28 after the intervention- Counting the number of colonies created by the collection of bacteria in the feces by microdilution culture on day 0 and 28 of the intervention.