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RecruitingNCT07667049Updated Oct 5, 2026

Gut Permeability and Microbiome in Preterm Infants

A Phase 1 interventional study of measurement of intestinal permeability in Prematurity Complications, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged Up to 4 Days. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University of Maryland, Baltimore · Phase 1, Interventional, and Screening

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 5, 2026Now RecruitingFirst site in United States+3 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
Up to 4 Days
Sex
All
01

Study summary

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.

02

Conditions studied

  • Prematurity Complications

Keywords

  • Intestinal permeability
  • necrotizing enterocolitis
  • preterm infants
  • dual sugar probe test
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 150 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.

Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 4 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

\<5 days Gestational age 24-32 weeks

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Lactulose-Rhamnose solution

    Drug: measurement of intestinal permeability

Interventions

  • Drugmeasurement of intestinal permeability

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

06

What researchers measure

Primary outcomes

  1. Measurement of intestinal permeability

    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).

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • van Elburg RM, Fetter WP, Bunkers CM, Heymans HS. Intestinal permeability in relation to birth weight and gestational and postnatal age. Arch Dis Child Fetal Neonatal Ed. 2003 Jan;88(1):F52-5. doi: 10.1136/fn.88.1.f52. PubMed 12496227 ↗
  • Noone C, Menzies IS, Banatvala JE, Scopes JW. Intestinal permeability and lactose hydrolysis in human rotaviral gastroenteritis assessed simultaneously by non-invasive differential sugar permeation. Eur J Clin Invest. 1986 Jun;16(3):217-25. doi: 10.1111/j.1365-2362.1986.tb01332.x. PubMed 3089818 ↗
  • Malagon I, Onkenhout W, Klok M, van der Poel PF, Bovill JG, Hazekamp MG. Gut permeability in neonates after a stage 1 Norwood procedure. Pediatr Crit Care Med. 2005 Sep;6(5):547-9. doi: 10.1097/01.pcc.0000175990.72753.97. PubMed 16148815 ↗
  • Piena M, Albers MJ, Van Haard PM, Gischler S, Tibboel D. Introduction of enteral feeding in neonates on extracorporeal membrane oxygenation after evaluation of intestinal permeability changes. J Pediatr Surg. 1998 Jan;33(1):30-4. doi: 10.1016/s0022-3468(98)90355-4. PubMed 9473094 ↗
  • Albers MJ, Steyerberg EW, Hazebroek FW, Mourik M, Borsboom GJ, Rietveld T, Huijmans JG, Tibboel D. Glutamine supplementation of parenteral nutrition does not improve intestinal permeability, nitrogen balance, or outcome in newborns and infants undergoing digestive-tract surgery: results from a double-blind, randomized, controlled trial. Ann Surg. 2005 Apr;241(4):599-606. doi: 10.1097/01.sla.0000157270.24991.71. PubMed 15798461 ↗
  • Rouwet EV, Heineman E, Buurman WA, ter Riet G, Ramsay G, Blanco CE. Intestinal permeability and carrier-mediated monosaccharide absorption in preterm neonates during the early postnatal period. Pediatr Res. 2002 Jan;51(1):64-70. doi: 10.1203/00006450-200201000-00012. PubMed 11756641 ↗
  • Piena-Spoel M, Albers MJ, ten Kate J, Tibboel D. Intestinal permeability in newborns with necrotizing enterocolitis and controls: Does the sugar absorption test provide guidelines for the time to (re-)introduce enteral nutrition? J Pediatr Surg. 2001 Apr;36(4):587-92. doi: 10.1053/jpsu.2001.22288. PubMed 11283883 ↗
  • Beach RC, Menzies IS, Clayden GS, Scopes JW. Gastrointestinal permeability changes in the preterm neonate. Arch Dis Child. 1982 Feb;57(2):141-5. doi: 10.1136/adc.57.2.141. PubMed 7065710 ↗
  • van Wijck K, Verlinden TJ, van Eijk HM, Dekker J, Buurman WA, Dejong CH, Lenaerts K. Novel multi-sugar assay for site-specific gastrointestinal permeability analysis: a randomized controlled crossover trial. Clin Nutr. 2013 Apr;32(2):245-51. doi: 10.1016/j.clnu.2012.06.014. Epub 2012 Aug 11. PubMed 22892368 ↗
  • van Wijck K, Bessems BA, van Eijk HM, Buurman WA, Dejong CH, Lenaerts K. Polyethylene glycol versus dual sugar assay for gastrointestinal permeability analysis: is it time to choose? Clin Exp Gastroenterol. 2012;5:139-50. doi: 10.2147/CEG.S31799. Epub 2012 Jul 19. PubMed 22888267 ↗
  • Bjarnason I. Intestinal permeability. Gut. 1994 Jan;35(1 Suppl):S18-22. doi: 10.1136/gut.35.1_suppl.s18. PubMed 8125384 ↗
  • Fasano A. Physiological, pathological, and therapeutic implications of zonulin-mediated intestinal barrier modulation: living life on the edge of the wall. Am J Pathol. 2008 Nov;173(5):1243-52. doi: 10.2353/ajpath.2008.080192. Epub 2008 Oct 2. PubMed 18832585 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
1 site added — first site in United States
Show site
  • University of Maryland · Baltimore, United States
Oct 5, 2026
Start date
Sep 15, 2026→Sep 30, 2026 (actual)
Oct 5, 2026
Primary completion
Sep 30, 2027→Oct 30, 2027
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • University of Maryland · Baltimore, United States
    Start date Sep 15, 2026→Sep 30, 2026 (now actual)
    Primary completion Sep 30, 2027→Oct 30, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07667049
Responsible party
Sripriya Sundararajan (Associate Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Jun 24, 2026
Start date
Sep 30, 2026
Primary completion
Oct 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Sripriya Sundararajan, MD
Contact
ssundararajan@som.umaryland.edu
4103286003
Bing Ma, PhD
Contact
ssundararajan@som.umaryland.edu
608-334-4877
Marcela Pasetti, PhD
principal investigator · University of Maryland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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