Probiotic and Synbiotic Supplementation for Constipation-related Outcomes in Children With Cerebral Palsy: a Randomized, Double-blind, Placebo-controlled Trial
Phase: NA
Conditions: Cerebral Palsy (CP), Constipation, Probiotic
Sponsor: Ordu University

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PARENT INFORMATION FORM 
We are conducting a new research study to evaluate the effectiveness of probiotic 
treatments, which are considered supportive therapies, for addressing growth, nutrition, and 
constipation problems in children with cerebral palsy. The title of the study is: 
“The Effect of Using Lactobacillus Reuteri and Prebiotic-Containing Lactobacillus 
Rhamnosus on Constipation and Weight Gain in Children with Cerebral Palsy: A 
Double-Blind Prospective Randomized Controlled Study.” 
We invite you and your child to participate in this study. However, participation is 
completely voluntary. You are free to decide whether or not to join. Before you make a 
decision, we would like to provide you with detailed information about the study. Please read 
this form carefully, and if you agree to participate after understanding the information, you 
may sign the form. 
The reason we are conducting this research is that cerebral palsy (CP) is a permanent 
disorder characterized by impaired voluntary motor activity and sensory function caused by 
damage to the developing brain tissue, leading to movement and posture abnormalities. 
Gastrointestinal problems occur in more than 90% of these patients, and constipation is seen 
in about 75%. These problems include indigestion, feeding difficulties, bloating, gagging, 
vomiting, constipation, and fecal incontinence, which are related to intestinal motility 
disorders. 
Studies have shown that disruption of the gut microbiota contributes to constipation. 
Some probiotic-based studies in children with cerebral palsy have demonstrated a reduction in 
constipation symptoms. Lactobacillus reuteri and Lactobacillus rhamnosus probiotics have 
been found beneficial and safe in current medical practice for various conditions such as 
infantile colic, functional constipation, obesity, necrotizing enterocolitis, and inflammatory 
bowel disease. In this study, we aim to investigate a supportive treatment that may help 
improve gastrointestinal, nutritional, and developmental problems in children with cerebral 
palsy. 
The study is planned to include 66 patients with cerebral palsy of similar functional 
levels. It will be conducted using three different probiotic formulations. The specific sample 
given to you will be determined randomly by Dr. Aybegüm Kalyoncu Ayçenk, and neither 
you nor other researchers will know which product your child receives. 
This research will be carried out by the Departments of Pediatric Surgery, Pediatrics, and 
Pediatric Neurology of Ordu University Faculty of Medicine. Your participation is important 
for the success of the study. 
If you agree to participate, you and your child will first be evaluated through a 
questionnaire and a physical examination performed by Dr. Aybegüm Kalyoncu Ayçenk or a 
member of her research team. If your doctor considers your child eligible, you will be 
included in the study. With your consent, you will be given a product sample to administer to 
your child once daily for 28 days. The product should be given every day at the same time. 
If product use cannot be maintained regularly, if any side effect occurs, or if hospitalization 
becomes necessary, your child will be withdrawn from the study. 
At the beginning and end of the study, a stool sample will be collected from your child. These 

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samples will be analyzed by researchers at the Ordu University Biochemistry Laboratory and 
then disposed of safely according to standard waste procedures. For families who have 
difficulty traveling to the hospital for the final evaluation, the research team may conduct the 
last examination and sample collection at your home, or transportation to the hospital will be 
arranged. 
 
Possible Side Effects of the Product: Probiotic products may rarely cause gas, bloating, 
diarrhea, or constipation. If any such symptoms occur, you should contact your study 
physician immediately. 
 
Financial Information: You will not be charged any fees to participate in this study. No 
payment will be made to participants. The probiotic products used in this research will be 
provided free of charge, and no additional costs will be requested from you. 
 
Confidentiality: All medical information related to you and your child will remain 
confidential. However, authorized monitors, ethics committees, or official authorities may 
access study data if required to ensure research quality. 
 
Voluntary Participation: You are free to refuse participation. Taking part in this study is 
completely voluntary, and if you decline, there will be no change to your child’s current 
treatment. 
You may also withdraw your consent at any time without providing a reason. 
 
Parent/Participant Statement 
Dr. Aybegüm Kalyoncu Ayçenk and her research colleagues from the Departments of 
Pediatric Surgery, Pediatrics, and Pediatric Neurology at Ordu University Faculty of Medicine 
have informed me about this medical research project. 
After receiving this information, I have been invited to participate as a “participant” in the 
study. 
I understand that my personal information will remain confidential and handled with 
care and respect during this research. I have been assured that my personal data will be 
protected when the results are used for educational or scientific purposes. 
I understand that I may withdraw from the study at any time without providing a 
reason (though I will notify the investigators beforehand when possible). I also understand 
that I may be excluded from the study by the investigators if medically necessary, without any 
harm to my child. 

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I will not bear any financial responsibility for study-related expenses, nor will I 
receive any payment for participation.  
In case of any health problem directly or indirectly related to the study, I have been 
assured that all necessary medical interventions will be provided without cost to me. 
If my child experiences any health issue during the study, I can contact Dr. Aybegüm 
Kalyoncu Ayçenk at (0452) 225 03 78 or at the Department of Pediatric Surgery, Ordu 
University Training and Research Hospital at any time. 
I understand that participation is voluntary and that my decision will not affect my 
child’s ongoing medical care or our relationship with the medical team. 
I have read and fully understood all explanations provided. After taking time to consider, I 
voluntarily agree for my child to participate in this research project with satisfaction and free 
will. 
A signed copy of this form will be provided to me. 
 
Mother: 
Name/Surname: 
Signature: 
Date: 
Father: 
Name/Surname: 
Signature: 
Date: 
Physician obtaining consent: 
Name/Surname: 
Signature: 
Date: