CLINICAL TRIALS PROFILE FOR LACTULOSE

All Clinical Trials for LACTULOSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00133406 ↗	Long-term Impact and Intervention for Diarrhea in Brazil	Unknown status	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2006-06-01	The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.
NCT00133406 ↗	Long-term Impact and Intervention for Diarrhea in Brazil	Unknown status	University of Virginia	Phase 3	2006-06-01	The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.
NCT00133562 ↗	HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2004-08-01	This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.
NCT00133562 ↗	HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition	Withdrawn	University of Virginia	Phase 3	2004-08-01	This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.
NCT00160264 ↗	Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women	Completed	Solvay Pharmaceuticals	Phase 4	2003-01-01	This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.
NCT00004796 ↗	Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis	Completed	Northwestern University	Phase 2	1994-11-01	OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.
NCT00004796 ↗	Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis	Completed	National Center for Research Resources (NCRR)	Phase 2	1994-11-01	OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.

Clinical Trial Conditions for LACTULOSE

Condition Name

Condition Name for LACTULOSE
Intervention	Trials
Hepatic Encephalopathy	40
Constipation	13
Liver Cirrhosis	13
Cirrhosis	10

Condition MeSH

Condition MeSH for LACTULOSE
Intervention	Trials
Hepatic Encephalopathy	51
Brain Diseases	50
Liver Cirrhosis	25
Fibrosis	23

Clinical Trial Locations for LACTULOSE

Trials by Country

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−

Trials by Country for LACTULOSE
Location	Trials
United States	141
China	23
India	19
United Kingdom	8
Egypt	6

Trials by US State

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−

Trials by US State for LACTULOSE
Location	Trials
New York	11
California	10
Virginia	8
Texas	7
Massachusetts	6

Clinical Trial Progress for LACTULOSE

Clinical Trial Phase

Clinical Trial Phase for LACTULOSE
Clinical Trial Phase	Trials
Phase 4	36
Phase 3	19
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for LACTULOSE
Clinical Trial Phase	Trials
Completed	71
Unknown status	24
Recruiting	24

Clinical Trial Sponsors for LACTULOSE

Sponsor Name

Sponsor Name for LACTULOSE
Sponsor	Trials
Valeant Pharmaceuticals International, Inc.	9
Bausch Health Americas, Inc.	8
Institute of Liver and Biliary Sciences, India	7

Sponsor Type

Sponsor Type for LACTULOSE
Sponsor	Trials
Other	214
Industry	56
NIH	8

Lactulose: Clinical Trials, Market Analysis, and Projections

Introduction to Lactulose

Lactulose is a synthetic disaccharide used primarily in the treatment of constipation and hepatic encephalopathy. It is a prebiotic that promotes the growth of beneficial bacteria in the gut, aiding in digestive health.

Clinical Trials: Lactulose vs Polyethylene Glycol 3350

Hepatic Encephalopathy Treatment

Several clinical trials have compared the efficacy of lactulose with polyethylene glycol 3350 (PEG) in treating hepatic encephalopathy (HE), a complication of cirrhosis.

• The HELP Study: This randomized clinical trial involved 50 patients with cirrhosis admitted for HE. Patients were randomized to receive either PEG or lactulose. The results showed that patients treated with PEG had a significantly lower mean HESA (Hepatic Encephalopathy Scoring Algorithm) score at 24 hours compared to those treated with lactulose (0.9 vs 1.6, P = .002)[1].
• Pooled Analysis: A meta-analysis of several RCTs indicated that PEG resulted in a significantly lower average HESA score at 24 hours, a higher proportion of patients with a reduction in HESA score by ≥1 grade, and a higher proportion of patients with a HESA score of 0 at 24 hours compared to lactulose. Additionally, PEG showed a shorter time to resolution of HE[4].

Efficacy and Safety

• Improvement Rates: In the HELP study, 43% of patients in the PEG group improved by 1 HESA grade, 39% by 2 grades, and 4% by 3 grades at 24 hours. In contrast, 36% of patients in the lactulose group improved by 1 grade, 12% by 2 grades, and 4% by 3 grades[1].
• Adverse Events: Both treatments were generally well-tolerated, but the study did not report significant differences in adverse events between the two groups.

Market Analysis

Global Market Size and Growth

• Current Market Size: The global lactulose market was valued at approximately $169.2 million in 2023[2].
• Projected Growth: The market is forecasted to grow to $217.4 million by 2030, with a compound annual growth rate (CAGR) of 3.6% during the period from 2024 to 2030[2].

Market Segmentation

• By Type: The market is segmented into crystalline lactulose and liquid lactulose. The enzymatic method of production, which ensures high purity and quality, is a significant contributor to the market[5].
• By Application: The primary applications are in the pharmaceutical and food industries. The pharmaceutical segment is growing rapidly due to the increasing recognition of lactulose's therapeutic properties in treating constipation and hepatic encephalopathy[5].

Key Players

• Major players in the lactulose market include Abbott, Morinaga, Solactis, Fresenius Kabi, Illovo, Biofac, and Dandong Kangfu. These companies are competing through product innovation, strategic partnerships, and geographical expansions[2].

Regional Market

• North America: This region is expected to hold the highest market share due to its strong pharmaceutical and food industries, well-established healthcare infrastructure, and high prevalence of digestive health issues[5].

Market Projections

Lactulose Concentrate Solution Market

• Market Size: The lactulose concentrate solution market was valued at $152.1 million in 2023 and is predicted to reach $172.9 million by 2031, growing at a CAGR of 1.7% from 2024 to 2031[5].
• Growth Drivers: The market is driven by increasing health consciousness, the expanding geriatric population, and the growing demand for effective gastrointestinal medications. Regulatory approvals and certifications are crucial for market growth[5].

Recent Developments

• Regulatory Approvals: In 2022, Biofac obtained regulatory approvals for its lactulose concentrate solution products, enabling the company to expand its product portfolio and reach new customer segments[5].
• Product Innovations: In 2021, Abbott introduced new formulations and improved existing ones to cater to evolving consumer preferences and market demands[5].

Competitive Landscape

The lactulose market is characterized by intense competition among key players. Companies are focusing on product innovation, strategic partnerships, and geographical expansions to strengthen their market position. The enzymatic method of production is gaining traction due to its advantages in terms of purity, yield, and environmental impact[5].

Key Takeaways

• Clinical Efficacy: PEG has shown superior efficacy over lactulose in treating hepatic encephalopathy in several clinical trials.
• Market Growth: The global lactulose market is projected to grow from $169.2 million in 2023 to $217.4 million by 2030.
• Segmentation: The market is segmented by type (crystalline and liquid lactulose) and application (pharmaceuticals and food industry).
• Regional Dominance: North America is expected to hold the highest market share due to its strong healthcare infrastructure and high demand for gastrointestinal medications.
• Competitive Strategies: Key players are focusing on product innovation, regulatory compliance, and geographical expansions.

FAQs

What is the primary use of lactulose in clinical settings?

Lactulose is primarily used in the treatment of constipation and hepatic encephalopathy, a complication of cirrhosis.

How does lactulose compare to PEG in treating hepatic encephalopathy?

Clinical trials have shown that PEG is more effective than lactulose in reducing HESA scores and achieving faster resolution of hepatic encephalopathy[1][4].

What is the forecasted market size of lactulose by 2030?

The global lactulose market is forecasted to reach $217.4 million by 2030, growing at a CAGR of 3.6% from 2024 to 2030[2].

Which region is expected to dominate the lactulose market?

North America is expected to hold the highest market share due to its strong pharmaceutical and food industries, and well-established healthcare infrastructure[5].

What are the key drivers of the lactulose market growth?

The market growth is driven by increasing health consciousness, the expanding geriatric population, and the growing demand for effective gastrointestinal medications[5].

Sources

1. Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution for Treatment of Overt Hepatic Encephalopathy: The HELP Randomized Clinical Trial. JAMA Internal Medicine, 2014.
2. Lactulose - Market, Report Size, Worth, Revenue, Growth, Industry. Valuates Reports.
3. Global Lactulose Market Report 2024 Edition. Cognitive Market Research.
4. Polyethylene glycol versus lactulose in the treatment of hepatic encephalopathy. BMJ Open Gastroenterology.
5. Lactulose Concentrate Solution Market Deep Analysis Report 2024. InsightAce Analytic.