Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children
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|ClinicalTrials.gov Identifier: NCT03639142|
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Functional Constipation||Other: Prunus domestica Drug: Polyethylene Glycol 4000||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children - Randomised Controlled Trial|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Experimental: Plum group
Children will receive plums at dose 3,5g/kg/d as an oral treatment for constipation.
Other: Prunus domestica
Patients will receive prunes at dose 3,5 g/kg/d (max.100mg/day) in three portions a day, for 4 weeks (amount of prescribed prunes will be calibrated with the weight that child ought to have on WHO growth charts at 50th percentile). Prunes should be introduced every day in three meals. Prunes can be chopped or grinded before eating them. They can be eaten alone or child may eat them as a part of bigger meal (which is preferred version). Prunes can be introduced with yogurt, cereals, nuts and seeds as a morning meal.
Active Comparator: Polyethylene glycol group
Children will receive PEG at dose 0,5g/kg/d as an oral treatment for constipation.
Drug: Polyethylene Glycol 4000
Patients will receive PEG at dose 0,5 g/kg/d once daily orally, for 4 weeks.
- The primary outcome measure will be treatment success [ Time Frame: up to 4 weeks ]≥3 spontaneous stools per week, without episodes of fecal soiling (in toilet-trained children), in the last week of the intervention (week 4).
- stool consistency (according to the Bristol Stool Form Scale) during whole study period [ Time Frame: up to 4 weeks ]
- frequency of defecation per week [ Time Frame: up to 4 weeks ]
- frequency of fecal soiling per week [ Time Frame: up to 4 weeks ]
- frequency of pain during defecation per week [ Time Frame: up to 4 weeks ]
- frequency of abdominal pain or flatulence per week [ Time Frame: up to 4 weeks ]
- need for intake of additional laxative treatment during whole study period [ Time Frame: up to 4 weeks ]
- adverse events [ Time Frame: up to 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639142
|Contact: Krzysztof Zakościelny||+48 email@example.com|
|Contact: Piotr Dziechciarz\||+48 firstname.lastname@example.org|