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Fiber Nutritional Supplement for Management of Constipation During Pregnancy

11. maj 2026 opdateret af: Société des Produits Nestlé (SPN)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventional
Fiber Nutritional Supplement with constipation counselling
Kosttilskud: fiber supplement (PHGG) with counselling for constipation management
fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in stool frequency from baseline to 4 weeks of intervention
Tidsramme: 4 weeks
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.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stool consistency including presence of diarrhoea
Tidsramme: 4 weeks
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.
4 weeks
Symptoms of constipation
Tidsramme: 4 weeks
percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week
4 weeks
Symptoms of gut discomfort
Tidsramme: 4 weeks
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)
4 weeks
Healthcare and pharmacological utilization
Tidsramme: 4 weeks
Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health
4 weeks
Product acceptance
Tidsramme: 4 weeks
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.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Société des Produits Nestlé (SPN)

Efterforskere

  • Ledende efterforsker: Flávia SantAnna Addor, MEDCIN PESQUISA CLINICA LTDA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. maj 2026

Primær færdiggørelse (Anslået)

8. august 2026

Studieafslutning (Anslået)

8. oktober 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26.01NPTC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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