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IRCT20260713070180N1 IRCT 2026-10-19 Shahre-kord University of Medical Sciences The Effect of Wheat Germ on Functional Constipation in Children Aged 10 to 14 Years Studying The Effect of Wheat Germ on Functional Constipation in Children Aged 10 to 14 Years :Single-Blind Randomized Clinical Trial 2026-10-24 anticipated 110 Recruiting https://irct.ir/trial/92570 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Individual Simple Randomization Participants will be assigned to two groups—an intervention group and a control group, each consisting of 55 individuals—using a random allocation method. To achieve this, 110 black and white cards will be mixed together in a container, and one card will be drawn at random for each patient, Blinding description: The patient is unaware of the type of intervention and medication, and both groups receive the medication in identical packages. 3 Functional constipation. Intervention 1: Intervention group:. Intervention 2: Control group:. Yes - There is a plan to make this available What will be shared: A subset of the data, including the Pidrolax dose and the effects of wheat germ on functional constipation and its adverse effects, will be shared When: The access period begins 6 months after publication of the results To whom: Researchers affiliated with academic and scientific institutions, medical students, and researchers employed in the pharmaceutical industry Conditions: Scientific research within the pharmaceutical industry can be employed to establish new protocols applicable to the administration of wheat germ in the treatment of pediatric functional constipation. Furthermore, the data are accessible to academic researchers. Where to obtain: To obtain the data, individuals may submit their requests via email to Leila Zolfaghari at leila.zolfaghari79@gmail.com How to obtain: Requests will be reviewed by the undersigned, Leila Zolfaghari, and, following verification of the identity of the individual or organization making the request by the Hajar Clinical Research Center and the relevant bodies at Shahrekord University of Medical Sciences, a response will be provided within approximately two months. Comments:
public Leila Zolfaghari
Isfahan, Imam Khomeini Street, Kowsar Residential Complex, Salman Farsi Boulevard, Roz Alley (7), No. 71, 2nd Floor
Esfahan Iran (Islamic Republic of) 8195618791 +98 31 3324 3014 leila.zolfaghari79@gmail.com Shahre-kord University of Medical Sciences scientific Dr Hassan Talakesh
Shahrekord – Parastar Street – Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816854633 +98 38 3110 7000 talakesh.h@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) informed consent to participate in the study Diagnosis of a functional disorder based on ROME IV criteria (meeting at least 2 of the 6 ROME IV criteria). Ages 10 to 14 10 years 14 years Both No use of laxatives in the preceding 4 weeks - Absence of hypothyroidism, fibrocystic condition, and intellectual disability. - No clinical history of gastrointestinal disease (celiac disease, inflammatory bowel disease, food allergy, or gastrointestinal surgery) Treatment - Drugs Treatment - Drugs Intervention group: Control group: Determining the effect of wheat germ on functional constipation in children aged 10 to 14 years. Timepoint: Participants will be assessed for functional constipation every 10 days using the Rome IV criteria. Method of measurement: Stool consistency and form will be assessed using the Bristol scale; dosage adjustments will be made based on these findings and recorded in each individual's questionnaire. Defecation with a sensation of incomplete evacuation. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Defecation with lumpy or hard stools. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Fecal incontinence. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Defecation with a sensation of anorectal obstruction or blockage. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Abdominal pain. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Straining during defecation. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Manual maneuvers to facilitate defecation. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Bowel movement frequency of fewer than 3 times per week. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Adverse events associated with the administration of Pidrolax and wheat germ. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Assessment of stool consistency and form. Timepoint: Every 10 days, based on the Bristol Stool Form Scale. Method of measurement: Entry into each participant's personal questionnaire. Bowel movement frequency per week. Timepoint: Every 10 days. Method of measurement: Entry into each participant's personal questionnaire. Shahrekord University of Medical Sciences Approved 2026-06-27 Ethics Committee of Shahrekord University of Medical Sciences Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences Educational Complex Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)