Fiber supplement plus counseling for constipation during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm study will enroll 31 pregnant women between 13 and 27 weeks gestation who meet Cullen 2007 criteria for functional constipation. Participants will take one sachet daily of Materna Opti fiber (about 5.8 g PHGG) for 4 weeks and receive standardized constipation counseling. The study assesses changes in constipation symptoms during the intervention period, alongside nutritional guidance. No control group is included, and outcomes will be collected through questionnaires in English.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pregnant women aged 21 years-old or above at recruitment
2. Gestational age of 13-27 weeks at recruitment
3. Singleton pregnancy at recruitment
4. 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:

   1. Low frequency of stool (\<3/week)
   2. Hard stools
   3. Difficulty on evacuation
5. Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.
6. Willing and able to comply with the requirements for participation in this study
7. 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
8. Able to respond to questionnaires in English

Exclusion Criteria:

1. Treated for constipation less than one week before the start of the study
2. Use of prebiotics or probiotics containing supplements two weeks prior to the study start
3. 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
4. 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
5. Not willing and/or not able to comply with the study procedures and requirements
6. Known serious food allergy
7. Known or suspected history of allergy or intolerance to the investigational product (IP)
8. Active participation in another clinical trial or on-going observational study
9. Family or hierarchical relationships with the research team members

Where it's running

• Medcin Pesquisa Clínica
  Osasco, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Flávia SantAnna Addor — Medcin Pesquisa Clinica Ltda
• Study coordinator: Alison Iroz, PhD
• Email: alison.petit-jean@nestle.com
• Phone: +44763720486

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.