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Gut Permeability and Microbiome in Preterm Infants

30 september 2026 uppdaterad av: Sripriya Sundararajan, University of Maryland, Baltimore

Gut Permeability and Microbiome in Very Low Birth Weight Preterm Neonates.

NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%. NEC symptoms mainly involve GI dysfunction, such as abdominal distension and feeding intolerance, but the presentation can be non-specific with few warning signs. Current therapies may be invasive, including surgical interventions that are often ineffective due to the rapid progression of the disease. Prematurity is the greatest risk factor for development of NEC due to physiological immaturity of the GI tract and altered levels of the normal GI microbiota. Several studies suggest that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis . Antenatal exposure to infection/inflammation may predispose the developing intestinal mucosa to subsequent injury or dysregulated inflammatory responses. Previous studies have linked presence of amniotic fluid infection/elevated cytokines, cord blood cytokines, and umbilical cord inflammation with risk for NEC in preterm neonates. In a rat model of NEC, maternal prenatal exposure to microbial LPS led to increased frequency and severity of intestinal injury. Taken together, these observations suggest that intestinal injury may be initiated in utero and contributes to increased IP at birth in the preterm neonate. Many of the defense mechanisms present in the mature intestine, such as peristalsis and tight junctions between intestinal epithelial cells are decreased in an immature intestine, and thus bacteria normally confined to the intestinal lumen are able to reach systemic organs and tissues. Bacterial translocation triggers the activation of an exaggerated inflammatory response, which leads to further epithelial damage. Our analysis of the initial cohort of 43 preterm infants, and others' previous studies have shown that IP is high at birth in preterms (<33wk gestation) with a rapid maturation of the intestinal barrier over the first 2 weeks. However, in some infants, high IP persisted and/or recurred in association with altered levels of the normal microbiota (bacteria community composition). Specifically, the investigators observed that (1) rapid maturation of intestinal barrier function, characterized by decreased IP, correlates with increased microbial community diversity (Figure 1), and most outstandingly, the increased abundance of beneficial bacteria Clostridiales (Figure 2); (2) Clostridiales is highly transcriptionally active and co-active with the probiotic bacterium Bifidobacterium; (3) neonatal factors, including early introduction of breast milk, shorter period of antibiotic exposure, and later gestational age, favor the early colonization of the gut microbiota by members of Clostridiales and Bifidobacterium, which altogether are associated with improved intestinal barrier in preterm infants; (4) low Clostridiales spp. abundance (<5%) and early gestational age (<31.7wk) were identified to be the most discriminatory features for elevated IP by supervised learning scheme, reaching an accuracy of 86.1%. (5) Clostridiales and Bifidobacteriales are the most abundant bacteria groups in later stages (phase II/III at 6-18 months of age) as shown in Figure 2, suggesting a process of gaining prosperity of these two bacterial groups during intestine development after birth. Altogether our preliminary results suggest the early colonization of the natural occurring probiotics strains Clostridiales and Bifidobacterium strongly associate with rapid maturation of intestinal barrier function, and their measurement are highly promising for early detection and as potential nutritional supplement to prevent NEC in the high-risk preterm population. Investigators propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La/Rh ratio. This continuation of the initial study builds on the previous findings that identified commensal bacteria Clostridiales and Bifidobacterium species as a strong indicator to the lowered IP and rapid maturation of intestinal barrier, to substantiate measurement of these probiotic strains combined with associated neonatal factors to form an accurate, rapid detection of intestinal permeability abnormality. The investigators propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La/Rh ratio.

Studieöversikt

Status

Rekrytering

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Fas 1

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • Rekrytering
        • University of Maryland
        • Kontakt:
        • Kontakt:
        • Underutredare:
          • Marcela Pasetti, Ph.D.
        • Underutredare:
          • Jose Lemme, Ph.D.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 4 dagar (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

<5 days Gestational age 24-32 weeks

Exclusion Criteria:

Nonviable or planned withdrawal of care

  • Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth >2 cm baseline), or bilious emesis/ aspirates.
  • Triplet or higher order multiple
  • Severe asphyxia
  • Lethal chromosome abnormalities
  • Cyanotic congenital heart disease
  • Intestinal atresia or perforation
  • Abdominal wall defects
  • Known galactosemia or other galactose intolerance

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Lactulose-Rhamnose solution

Measure intestinal permeability by use of non-digestable sugars known to not cross the intestinal barrier in normal healthy intestinal tissue.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measurement of intestinal permeability
Tidsram: 1 year

The study outcome measures will be intestinal permeability (quantitative) and leaky gut (binary). Increased levels of urine Lactulose/Rhamnose [La/Rh] ratio >0.05 will identify infants with increased intestinal permeability (IP).

1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Marcela Pasetti, PhD, University of Maryland

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 september 2026

Primärt slutförande (Beräknad)

30 oktober 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

24 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HP-00110340
  • 125-10212000-M33003-TPPRGGRT-2 (Annat bidrag/finansieringsnummer: University of Maryland School of Medicine)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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