Fuyang Fifth People's Hospital Quanying Branch
Fuyang, Anhui, China
NCT Number: NCT07002489
The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years old). The main questions it aims to answer are:
- Does Notrande Shuhuajun Probiotic Supplement intake improve functional constipation in preschool children?
105 eligible participants will be enrolled in one center and assigned the study product. After one week washout period participants need to take in the product for two weeks, followed by a one-week regression period.
Researchers will collect data, analyze data and conclude whether the study product is effective to improve constipation in participants, by comparing the change of concentration of biochemical indicators SCFA (Short-chain fatty acids), Lactobacillus and Bifidobacterium, and visual analysis of Bristol Stool scale etc..
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Notify Me3 year–6 year
All sexes
Interventional
Not applicable
Fuyang, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase).
Time frame: day 0, day 14, and day 21
Change of constipation indicators: SCFA (Short-chain fatty acids) level in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: mg/100g fecal sample, higher level means improved constipation.
Time frame: day 0, day 14, and day 21
Change of constipation indicators: Probiotics - Lactobacillus and Bifidobacterium concentration level via qPCR in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: CFU/g, higher level means improved constipation.
Time frame: day 0 , day 21
Change of Bristol Stool Form Scale (BSFS) by visual judgement of look and form of participants' bowel movements, type 1 to type 7, mapping to score 1 to 7, the smaller value indicates improved constipation.
Shandong Sibote Biotechnology Co., Ltd.
Industry
A Single-arm, Open-label Study of Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children Aged 3-6
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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