Fiber Nutritional Supplement for Management of Constipation During Pregnancy
Effectiveness of Daily Supplementation of a Fiber Nutritional Supplement (Materna® Opti-fiber) and Counselling for Constipation Management in Pregnancy
This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being.
The study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alison Iroz, PhD
- 电话号码：+44763720486
- 邮箱：alison.petit-jean@nestle.com
研究联系人备份
- 姓名：Irma Silva Zolezzi, PhD
- 邮箱：Irma.SilvaZolezzi@nestle.com
学习地点
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São Paulo
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Osasco、São Paulo、巴西、06023-070
- Medcin Pesquisa Clínica
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接触：
- Flávia Alvim S. Addor, Profa. Dra.
- 电话号码：+55 11 94311-7296
- 邮箱：contato@medcindermatologia.com.br
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Pregnant women aged 21 years-old or above at recruitment
- Gestational age of 13-27 weeks at recruitment
- Singleton pregnancy at recruitment
Suffering from functional constipation according to the Cullen 2007 criteria which must include ALL the following and the criteria must be fulfilled for at least two weeks with symptom onset during pregnancy:
- Low frequency of stool (<3/week)
- Hard stools
- Difficulty on evacuation
- Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.
- Willing and able to comply with the requirements for participation in this study
- Willing and able to refrain from consuming other supplements containing fiber, prebiotics, or probiotics other than the Fiber Nutritional Supplement (Materna® Opti-fiber) over the intervention period
- Able to respond to questionnaires in English
Exclusion Criteria:
- Treated for constipation less than one week before the start of the study
- Use of prebiotics or probiotics containing supplements two weeks prior to the study start
- Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
- Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
- Not willing and/or not able to comply with the study procedures and requirements
- Known serious food allergy
- Known or suspected history of allergy or intolerance to the investigational product (IP)
- Active participation in another clinical trial or on-going observational study
- Family or hierarchical relationships with the research team members
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Interventional
Fiber Nutritional Supplement with constipation counselling
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fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in stool frequency from baseline to 4 weeks of intervention
大体时间：4 weeks
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Change in stool frequency from baseline (V1) to 4 weeks of intervention (V2) assessed using a Gut Health Questionnaire to capture transit time and frequency.
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stool consistency including presence of diarrhoea
大体时间：4 weeks
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Change in stool consistency from baseline (V1) to 4 weeks of intervention (V2) based on a 7-point Bristol Stool Scale (1=Hard, 7= Watery), including self-reported presence of diarrhoea.
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4 weeks
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Symptoms of constipation
大体时间：4 weeks
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percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week
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4 weeks
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Symptoms of gut discomfort
大体时间：4 weeks
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Frequencey of self-reported presence of abdominal pain, abdominal discomfort abdominal bloating, gassiness / flatulence), and/or pain during defecation (completed at V2 only following 4 weeks of intervention)
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4 weeks
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Healthcare and pharmacological utilization
大体时间：4 weeks
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Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health
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4 weeks
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Product acceptance
大体时间：4 weeks
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Self-reported score rom 1 - 5, where 1 = "Very poor", 5 = "Excellent" on product acceptance and ease of use after 4 weeks of intervention (completed at V2 only) using a questionnaire developed for the study.
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4 weeks
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合作者和调查者
调查人员
- 首席研究员：Flávia SantAnna Addor、MEDCIN PESQUISA CLINICA LTDA
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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