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

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 referred to the Imam Rezaclinic in 1401 - a triple-blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220410054474N1

Enrollment

Registered

2022-05-24

Start date

2022-05-22

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia. Acute lymphoblastic leukemia, in remission

Interventions

Intervention 1: Intervention group: Intervention group: The traditional product of "wheat bran" is given to the case group as a "complementary food". It should be eaten once a day for four weeks. The

Eligibility

Sex/Gender

All

Age

3 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
"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 intervention"Blood 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.	—

Measure

Time frame

"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 intervention"Blood 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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaba Barkhori mehni

Shiraz University of Medical Sciences

saba.barkhori@gmail.com+98 71 3234 5145

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026