Studying The Effect of Wheat Germ on Functional Constipation in Children Aged 10 to 14 Years :Single-Blind Randomized Clinical Trial

Overall objective: Determine the effect of wheat germ on functional constipation in children aged 10–14. Specific objectives (compare between groups): - Prevalence of functional constipation - Prevalence of: straining, lumpy/hard stools (Bristol), incomplete evacuation, anorectal obstruction/blockage, manual maneuver >once/week, <3 bowel movements/week, abdominal pain and bloating, fecal incontinence - Mean bowel movements/week and mean stool consistency score (Bristol) - Side effects of pidrolax vs. wheat germ

This is a randomized, single-blind, controlled clinical trial with a factorial design involving 110 patients. Random assignment was performed by placing 110 black and white cards into a container and randomly drawing one card for each patient.

This clinical trial compares polyethylene glycol (1 g/kg) plus 15 g of wheat germ daily versus polyethylene glycol (1 g/kg) alone over 12 weeks in children aged 10–14 with functional constipation from the Imam Ali Clinic. It is single-blind, with patients unaware of their group, and all medication packaged identically.

- Providing informed consent - Diagnosis of functional constipation based on ROME IV criteria - Age 10 to 14 years - No use of laxatives in the preceding 4 weeks - Absence of hypothyroidism, fibrocystic disease, or intellectual disability - No clinical history of gastrointestinal disorders

One group receives 1 g polyethylene glycol per dose (Sepidaj Company) plus 15 g wheatgrass daily; the control group receives 1 g polyethylene glycol daily. Treatment duration is 12 weeks.

If positive results are obtained regarding wheat germ's effect on functional constipation in children aged 10–14, it could serve as a suitable, side-effect- free alternative for better management of this condition.

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.

The patient is unaware of the type of intervention and medication, and both groups receive the medication in identical packages.

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

The access period begins 6 months after publication of the results

Researchers affiliated with academic and scientific institutions, medical students, and researchers employed in the pharmaceutical industry

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.

To obtain the data, individuals may submit their requests via email to Leila Zolfaghari at leila.zolfaghari79@gmail.com

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.