Clinical trial: An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children (NCT00403897)

Eligibility criteria:
Inclusion Criteria:

          -  children aged 24 months - 11 years old inclusive

          -  patients with constipation defined as:

               -  ≤ 2 spontaneous complete bowel movements per week (over the previous 14 days),
                  and one or more of the following:

                    -  1/4 or more of bowel movements with straining

                    -  1/4 or more of bowel movements with hard or lumpy stools

          -  patients in whom these symptoms have been present for ≥ 3 months

          -  new patients or those whose management is unsatisfactory on current laxative treatment

          -  patients of either sex

          -  patients of any ethnic origin

          -  hospital in-patients or outpatients.

        Exclusion Criteria:

        Patients with:

          -  history of bowel washout within the last 2 months

          -  intestinal perforation or history of obstruction

          -  recent history of urinary tract infection (within last month)

          -  Hirschsprungs disease

          -  paralytic ileus

          -  toxic megacolon

          -  severe inflammatory conditions of the intestinal tract

          -  clinically uncontrolled renal/hepatic/cardiac disease(s)

          -  clinically uncontrolled endocrine disorder(s)

          -  any other severe unstable co-existing disease

          -  hypersensitivity to macrogol or other constituents of Movicol

          -  encopresis

          -  patients who have taken any investigational drug in the last three months

          -  patients or patients whose parents would in the opinion of the investigator be unable
             to comply with the requirements of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
Subject must be at most 11 Years

Patient description (medical language): A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days.  The patient has had constipation and discomfort with bowel movements since birth.  His symptoms worsened after eating semi-solid foods.  Vital signs are normal.  Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds.  Xray with barium shows a narrow rectum and rectosigmoid area.  The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine.

Patient description (patient's own words): My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine.

Does the patient match the trial criteria? Contradiction