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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alison Iroz, PhD
- 전화번호: +44763720486
- 이메일: alison.petit-jean@nestle.com
연구 연락처 백업
- 이름: Irma Silva Zolezzi, PhD
- 이메일: Irma.SilvaZolezzi@nestle.com
연구 장소
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São Paulo
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Osasco, São Paulo, 브라질, 06023-070
- Medcin Pesquisa Clínica
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연락하다:
- Flávia Alvim S. Addor, Profa. Dra.
- 전화번호: +55 11 94311-7296
- 이메일: contato@medcindermatologia.com.br
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in stool frequency from baseline to 4 weeks of intervention
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Stool consistency including presence of diarrhoea
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Flávia SantAnna Addor, MEDCIN PESQUISA CLINICA LTDA
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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