Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

NCT01210625 | Unknown

• 1 other identifier: Nutrabiotix
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that daily oral intake of starch-entrapped alginate microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal "typical" side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents; and promote gut health by improving bowel habit, by changing the gut microbiota and increasing production of short chain fatty acids, especially butyrate, in the colon and decreasing production of protein putrification (prebiotic effects).

Conditions

Constipation

Keywords

Constipation

Interventions

Nutrabiotix DIETARY_SUPPLEMENT

Fiber supplement: 9mg or 12mg

Psyllium DIETARY_SUPPLEMENT

12g total per day (4 capsules containing 1 gram psyllium fiber 3 times a day)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, asymptomatic 18 to 65 years subjects with BMI 20-30 and self described unsatisfactory bowel habit

You may not qualify if:

• Abnormalities in CBC (Hgb \<12 g/dL, platelet count \<100 000, WBC \<4000 or \>10 000);
• Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin \>1.5 times normal range);
• Abnormal renal function tests (BUN or creatinine \>1.5 times normal range);
• Low serum albumin (\<3 g/dL);
• \) Abnormal TSH level;
• (6) High CRP;
• (7) Significant GI symptoms (except for constipation or occasional rectal bleeding due to hemorrhoids);
• (8) Prior intestinal resection;
• (9) Patient history of GI diseases \[except for hemorrhoids or occasional (\<3 times a week) heartburn\];
• (10) Antibiotic use within last 12 weeks prior to enrollment;
• (11) Lean (BMI \<25) or obese (BMI\>30) subjects because obesity could be associated with abnormal microbiota;
• (12) Significant cardiac or respiratory diseases (defined by requiring daily medication for management of their diseases);
• (13) Severe hypertension (defined as uncontrolled hypertension in spite of therapy, or requirement of more than one medication to treat hypertension; well-controlled, mild hypertension may be included);
• (14) Insulin-requiring and/or poorly controlled diabetes (well-controlled diabetics with HbA1c \<6 may be enrolled);
• (15) Significant psychological disorders;

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Rasmussen HE, Hamaker B, Rajan KB, Mutlu E, Green SJ, Brown M, Kaur A, Keshavarzian A. Starch-entrapped microsphere fibers improve bowel habit but do not exhibit prebiotic capacity in those with unsatisfactory bowel habits: a phase I, randomized, double-blind, controlled human trial. Nutr Res. 2017 Aug;44:27-37. doi: 10.1016/j.nutres.2017.05.015. Epub 2017 Jun 2.

  PMID: 28821315 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Michael Brown, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 28, 2010
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

US (1)