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Holigos® IBS Restore helps patients suffering from all IBS subtypes to have more consistent stools, less abdominal pain, and decreased bloating.1,2

Clinical Benefits Clinical White Paper Mechanism of Action Safety & Tolerability Dosing

Clinical Benefits

Holigos® IBS Restore is clinically proven to help provide relief in all IBS subtypes.^1-2

In a 12-week, open-label, multi-center study (N=317),* Holigos® IBS Restore demonstrated multiple benefits^1-2

Decreased Severity

IBS symptom severity changed from severe to mild by Week 12, as measured by the IBS-severity scoring system (IBS-SSS)^‡

Over 86% of patients had a clinically significant improvement in their IBS-SSS total score by Week 12^‡

A reduction of 50 points or more in the IBS-SSS total score is considered clinically significant⁷

58% decrease in abdominal pain severity per IBS-SSS pain component, P<0.0001^‡

Overall IBS Severity Score

Fewer Days with Pain

Reduced from an average of 6.0 to 2.5 days within the prior 10 days, P<0.0001^2‡

More Normal Stools

Over 4.6-fold increase in normal stools from a baseline of 9% as measured by the Bristol Stool Form Scale (BSFS)^2||

Improved Quality of Life

48% increase in quality-of-life (QOL) scores using the IBS-QOL assessment, P<0.0001^2¶

Patients experienced improvement in abdominal pain, bloating, and stool consistency in as early as 4 weeks.^1-2

Similar efficacy shown across all IBS subtypes.^1-2

All results are based on the intention-to-treat population.

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Mechanism of Action of Holigos® IBS Restore

While others target the symptoms, we target the source.

Bacterial dysbiosis is a key driver of IBS pathology and is common in patients with IBS.^10-15

Microbiome dysbiosis can impair normal gut metabolism, which can exacerbate symptoms of IBS.^{10,11,13,16,17}

Abnormal gut metabolism disrupts gut barrier function and can exacerbate symptoms of IBS.^13,18-20

The glycans in Holigos® IBS Restore act as selective prebiotics to help rebalance the gut microbiome and increase production of beneficial metabolites.^2-4,9,21,22

The glycans in Holigos® IBS Restore improve gut barrier integrity and gut motility.^2,10,11,18

Holigos® IBS Restore helps reduce symptoms by providing dietary management for patients with IBS.^1,2

Safety & Tolerability

Holigos® IBS Restore is safe and well-tolerated.^1,3-6

In a double-blinded, placebo-controlled trial, it was demonstrated that^2,3:

No difference in reported adverse events between Holigos® IBS Restore and placebo.

No serious adverse events with
Holigos® IBS Restore or placebo reported.

Common side effects associated with Holigos® IBS Restore included mild local reactions in the gut, such as abdominal pain, distension, and flatulence.

The ingredients in the Holigos® family of products are safe and well-tolerated by infants, children, adults, and patients with IBS.^3-6

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5

Holigos® IBS Restore is a proprietary formulation of the glycans 2’-FL and LNnT. The ingredients in Holigos® IBS Restore have been positively reviewed by the FDA and EFSA and accepted as safe.^23-26

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

2'-FL=2'-Fucosyllactose; LNnT=Lacto-N-neotetraose.

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

2'-FL=2'-Fucosyllactose; LNnT=Lacto-N-neotetraose.

Interested in wholesale opportunities?

Connect with our team today:

Email: contact@holigos.com

Footnotes & References

The GRIPS clinical trial was a 12-week, multi-center, open-label trial in patients with IBS (ITT, N=317) to assess the potential for Holigos® IBS Restore to induce and support normal bowel habits and improve symptoms of IBS. The primary endpoint was effect on stool consistency. Select secondary outcomes included: IBS-SSS total score, IBS-SSS abdominal pain severity and stool frequency, IBS-SSS abdominal distension severity, and health-related quality of life.
The IBS-SSS assesses symptom severity by measuring abdominal pain intensity and frequency, abdominal distension, dissatisfaction with bowel habits, and life interference of IBS during the preceding week. The total IBS-SSS score ranges between 0 and 500; a higher score indicates more severe symptoms.7
The BSFS classifies the form of human feces into seven categories, running from 1=“separate hard lumps” to 7=“watery”. Abnormal stools is the total % of all stools that are either Bristol Types 1-2 or 6-7.27
The IBS-QOL measures the impact of IBS and its treatment, which consists of 34 items; a higher score indicates better QOL.28

References

Simrén M. Human milk oligosaccharides improve all the central symptoms of irritable bowel syndrome: a multi-center, open label trial. In: American College of Gastroenterology. San Antonio; 2019.
Data on File. Glycom A/S. 2019.
Iribarren C, Törnblom H, Aziz I, et al. The effects of human milk oligosaccharides on bifidobacteria and gastrointestinal symptoms in irritable bowel syndrome patients: a parallel, double blind, randomized, placebo-controlled trial. Gastroenterology. 2019;156(6 Suppl1):S-235.
Elison E, Vigsnaes LK, Krogsgaard LR, et al. Oral supplementation of healthy adults with 2’-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr. 2016;116(8):1356-1368.
Puccio G, Alliet P, Cajozzo C, et al. Effects of infant formula with human milk oligosaccharides on growth and morbidity: A randomized multicenter trial. J Pediatr Gastroenterol Nutr. 2017;64(4):624-631.
Storm HM, Shepard J, Czerkies LM, et al. 2′-Fucosyllactose is well tolerated in a 100% whey, partially hydrolyzed infant formula with bifidobacterium lactis: a randomized controlled trial. Glob Pediatr Heal. 2019;6:1-10.
Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: A simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11(2):395-402.
Wald A. Treatment of irritable bowel syndrome in adults. In: Nicholas JT, Shilpa G. UpToDate. https://www.uptodate.com/contents/treatment-of-irritable-bowel-syndrome-in-adults/. Published 2019. Accessed July 16, 2019.
Koropatkin NM, Cameron EA, Martens EC. How glycan metabolism shapes the human gut microbiota. Nat Rev Microbiol. 2012;10(5):323-335.
Duboc H, Rainteau D, Rajca S, et al. Increase in fecal primary bile acids and dysbiosis in patients with diarrhea-predominant irritable bowel syndrome. Neurogastroenterol Motil. 2012;24(6).
Dior M, Delagrèverie H, Duboc H, et al. Interplay between bile acid metabolism and microbiota in irritable bowel syndrome. Neurogastroenterol Motil. 2016;28(9):1330-1340.
Bennet SMP, Sundin J, Magnusson MK, et al. Altered intestinal antibacterial gene expression response profile in irritable bowel syndrome is linked to bacterial composition and immune activation. Neurogastroenterol Motil. 2018;30(12):1-15.
Rajilić-Stojanović M, Jonkers DM, Salonen A, et al. Intestinal microbiota and diet in IBS: Causes, consequences, or epiphenomena? Am J Gastroenterol. 2015;110(2):278-287.
Rajilić-Stojanović M, Biagi E, Heilig HGHJ, et al. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011;141(5):1792-1801.
Ford AC, Quigley EMM, Lacy BE, et al. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014;109(10):1547-1562.
Bhattarai Y, Muniz Pedrogo DA, Kashyap PC. Irritable bowel syndrome: a gut microbiota-related disorder? Am J Physiol Liver Physiol. 2017;312(1):G52-G62.
Postler TS, Ghosh S. Understanding the holobiont: How microbial metabolites affect human health and shape the immune system. Cell Metab. 2017;26(1):110-130.
Camilleri M, Lasch K, Zhou W. Irritable bowel syndrome: Methods, mechanisms, and pathophysiology. The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303(7):G775-G785.
Lin L, Zhang J. Role of intestinal microbiota and metabolites on gut homeostasis and human diseases. BMC Immunol. 2017;18(1):1-25.
Martínez C, González-Castro A, Vicario M, Santos J. Cellular and molecular basis of intestinal barrier dysfunction in the irritable bowel syndrome. Gut Liver. 2012;6(3):305-315.
Jalanka-Tuovinen J, Salonen A, Nikkilä J, et al. Intestinal microbiota in healthy adults: Temporal analysis reveals individual and common core and relation to intestinal symptoms. PLoS One. 2011;6(7).
Bode L. The functional biology of human milk oligosaccharides. Early Hum Dev. 2015;91(11):619-622.
US FDA, Agency response letter GRAS Notice No. GRN 000650 [2’-O-Fucosyllactose, Glycom A/S]. College Park (MD), US Food and Drug Administration (US FDA), Center for Food Safety & Applied Nutrition (CFSAN), Office of Food Additive Safety, 2016.
US FDA, Agency response letter GRAS Notice No. GRN 000659 [Lacto-N-neotetrose, Glycom A/S]. College Park (MD), US Food and Drug Administration (US FDA), Center for Food Safety & Applied Nutrition (CFSAN), Office of Food Additive Safety, 2016.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Safety of lacto-N-neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97. EFSA Journal. 2015;13(7):4183.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Safety of 2’-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97. EFSA Journal. 2015;13(7):4184.
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32(9):920-924. Accessed July 17, 2019.
Patrick DL, Drossman DA, Frederick IO, Dicesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: Development and validation of a new measure. Dig Dis Sci. 1998;43(2):400-411.
US Food & Drug Administration. Medical foods guidance documents & regulatory information. https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/medical-foods-guidance-documents-regulatory-information. Accessed July 16, 2019.

Holigos® IBS | Restore

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.^1-6

Holigos® IBS | Restore

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.^1-6

Holigos® IBS Restore helps patients suffering from all IBS subtypes to have more consistent stools, less abdominal pain, and decreased bloating.1,2

Clinical Benefits

Holigos® IBS Restore is clinically proven to help provide relief in all IBS subtypes.^1-2

Decreased Severity

Overall IBS Severity Score

Fewer Days with Pain

More Normal Stools

Improved Quality of Life

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Mechanism of Action of Holigos® IBS Restore

Safety & Tolerability

Holigos® IBS Restore is safe and well-tolerated.^1,3-6

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

Footnotes & References

References

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Holigos® IBS | Restore

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.1-6

Holigos® IBS | Restore

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.1-6

Holigos® IBS Restore helps patients suffering from all IBS subtypes to have more consistent stools, less abdominal pain, and decreased bloating.1,2

Clinical Benefits

Holigos® IBS Restore is clinically proven to help provide relief in all IBS subtypes.1-2

Decreased Severity

Overall IBS Severity Score

Fewer Days with Pain

More Normal Stools

Improved Quality of Life

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Clinical white paper

Download our clinical white paper to learn about the benefits of Holigos® IBS Restore.

Mechanism of Action of Holigos® IBS Restore

Safety & Tolerability

Holigos® IBS Restore is safe and well-tolerated.1,3-6

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.2-5

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

Dosing

Holigos® IBS Restore is a medical food available as a once-daily dose.

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.2-5

Holigos® IBS Restore does not contain gluten, artificial colors or flavors, added sugar, or yeast. Shelf-stable, Holigos® IBS Restore does not have refrigeration or special storage requirements.

Footnotes & References

References

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.^1-6

Relief for patients that’s safe, well-tolerated, and effective in a once-daily dose.^1-6

Holigos® IBS Restore is clinically proven to help provide relief in all IBS subtypes.^1-2

Holigos® IBS Restore is safe and well-tolerated.^1,3-6

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5

Holigos® IBS Restore is easy to take and has been formulated to help normalize the gut microbiota.^2-5