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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alison Iroz, PhD
- 電話番号：+44763720486
- メール：alison.petit-jean@nestle.com
研究連絡先のバックアップ
- 名前：Irma Silva Zolezzi, PhD
- メール：Irma.SilvaZolezzi@nestle.com
研究場所
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São Paulo
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Osasco、São Paulo、ブラジル、06023-070
- Medcin Pesquisa Clínica
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コンタクト：
- Flávia Alvim S. Addor, Profa. Dra.
- 電話番号：+55 11 94311-7296
- メール：contato@medcindermatologia.com.br
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in stool frequency from baseline to 4 weeks of intervention
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stool consistency including presence of diarrhoea
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Flávia SantAnna Addor、MEDCIN PESQUISA CLINICA LTDA
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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